HIV Infections
Conditions
Keywords
Human Immunodeficiency Virus
Brief summary
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) \< 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
Detailed description
This study was originally planned as a 48-week, Phase 3, randomized, open-label, multicenter study comparing EFV+FTC+TDF (administered as the individual component drugs) versus CBV (lamivudine/zidovudine) + EFV to assess the efficacy and safety of both treatments in ART-Naive, HIV-1 infected participants. The regimen of CBV (administered twice daily) + EFV (administered once daily) served as the active control treatment and was compared with the regimen of EFV+FTC+TDF; each component drug in the EFV+FTC+TDF regimen was administered once daily. Week 48 to Week 96: The study was extended and continued to evaluate the efficacy and safety of the two regimens up to a total treatment duration of 96 weeks. The regimen of EFV+FTC+TDF continued to be dosed as the component drugs (EFV + FTC + TDF), once daily, without regard to meals. The regimen of CBV+EFV was dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals). Week 96 to Week 144: A further study extension changed the 3-pill EFV+FTC+TDF regimen to a 2-pill regimen of EFV + Truvada (\[TVD\]: a fixed-dose combination pill containing FTC/TDF), once daily without regard to meals, and continued to evaluate the efficacy and safety of the two regimens for a further 48 weeks up to a total study treatment duration of 144 weeks. The regimen of CBV+EFV continued to be dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals). Week 144 to end of study (Week 240): A final study extension provided all study participants from both treatment regimens the option to switch their respective treatments to the 1-pill regimen of for a further 96 weeks up to a total study duration of 240 weeks (5 years) to further assess the efficacy and safety of ART regimen simplification. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Interventions
Capsule containing 200 mg FTC, taken once daily, for 96 weeks
Tablet containing 300 mg TDF, taken once daily, for 96 weeks
DRUGEfavirenz (EFV)
Tablet containing 600 mg EFV, taken once daily, for 96 weeks
DRUGFTC/TDF
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144
DRUGFTC/TDF/EFV
Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240
DRUGLamivudine/zidovudine
Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must have met all inclusion criteria within 28 days prior to randomization unless specified otherwise including: * Plasma HIV-1 RNA levels greater than 10,000 c/mL using Roche Amplicor HIV-1 Monitor Test Version 1.5 Standard * Adequate renal function: Calculated creatinine clearance greater than or equal to 50 mL/min according to the Cockcroft-Gault Formula. * Hepatic transaminases (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) 3 x upper limit of normal (ULN). * Total bilirubin less than or equal to 1.5 mg/dL. * Adequate hematologic function (absolute neutrophil count greater than or equal to 1,000/mm\^3; platelets greater than or equal to 50,000/mm\^3; hemoglobin greater than or equal to 8.0 g/dL). * Serum amylase less than or equal to 1.5 x ULN. * Serum phosphorus greater than or equal to 2.2 mg/dL. * Willingness to use effective contraception by both males and females while on study treatment and for 30 days following study drug completion. * Life expectancy greater than or equal to 1 year * The ability to understand and sign written informed consent form obtained prior to initiation of study procedures.
Exclusion criteria
Participants were not eligible for entry to the study if any of the following were met: * Prior treatment with any non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), or protease inhibitor (PI). * A new AIDS-defining condition diagnosed (exception CD4 criteria) within 30 days of baseline. * Receiving ongoing therapy with any of the following: nephrotoxic agents, probenecid, systemic chemotherapeutic agents, systemic corticosteroids, interleukin-2, drugs that interact with efavirenz. Administration of any of the above medications must be discontinued at least 30 days prior to baseline visit and for duration of study. * Pregnant or lactating participants. * Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Participants with biopsy-confirmed KS were eligible but must not have received any systemic therapy for KS within 30 days of baseline and not anticipated starting systemic therapy during the study. * Prior history of renal or bone disease. * Any other clinical condition prior to therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm | 48 weeks | Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 48 visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) | Week 48 | Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 48 visit. |
| Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. | 48 weeks | The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 | 48 Weeks | The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 | Baseline to 48 weeks | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 | Baseline to 48 Weeks | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 | Baseline to 48 Weeks | Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 | Study baseline to Week 48 | Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). |
| Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 | Study baseline to Week 48 | Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | 96 Weeks | Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 96 visit. |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | Week 96 | Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 96 visit. |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 | Week 96 | TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA \< 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA \> 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 | Week 96 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 | Week 96 | Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 | Week 96 | Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 | Study baseline to Week 96 | Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). |
| Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 | Baseline to Week 96 | Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value |
| Change in Limb Fat (kg) From Week 48 to Week 96 | Week 48 to Week 96 | Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. |
| Change in Trunk Fat (kg) From Week 48 to Week 96 | Week 48 to Week 96 | Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value |
| Change in Total Body Fat (kg) From Week 48 to Week 96 | 48 weeks to 96 weeks | Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | 144 weeks | Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV-1 RNA levels \< 400 c/mL prior to Week 144 visit. |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | Week 144 | Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV-1 RNA levels \< 50 c/mL prior to Week 144 visit. |
| Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 | Week 144 | The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 | Week 144 | The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 | Week 144 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 | Week 144 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 | Week 144 | Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 | Week 144 | Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 | Study baseline to Week 144 | Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). |
| Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 | Baseline to Week 144 | Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value |
| Change in Limb Fat (kg) From Week 48 to Week 144 | Week 48 to Week 144 | Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value |
| Change in Trunk Fat (kg) From Week 48 to Week 144 | Week 48 to Week 144 | Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value |
| Change in Total Body Fat (kg) From Week 48 to Week 144 | Week 48 to Week 144 | Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) | Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 240 visit. |
| Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) | Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 240 visit. |
| Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) | Week 240 (Atripla Week 96) | The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) | Week 240 (Atripla Week 96) | The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1. |
| Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) | Week 240 (Atripla Week 96) | Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) | Week 240 (Atripla Week 96) | Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) | Study/Atripla baseline to Week 240 (Atripla Week 96) | Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value |
| Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value |
| Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value |
| Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value |
| Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied). |
| Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 | Baseline to 48 Weeks | Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. |
| Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied). |
| Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied). |
| Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly). |
| Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). |
| Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). |
| Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied). |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 70 study sites in the United States and Europe. The first participant was screened on 29 July 2003; the last participant was randomized on 16 January 2004; the last participant observation for the primary endpoint analysis was 11 February 2005; the last participant last visit for end of study analysis was 10 June 2009.
Pre-assignment details
Of the 517 enrolled participants, 6 received no study drug (the safety analysis set was therefore 511 participants: 257 \[efavirenz+emtricitabine+tenofovir disoproxil fumarate group\] and 254 \[efavirenz+combivir group\], respectively).
Participants by arm
| Arm | Count |
|---|---|
| EFV+FTC+TDF Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.
At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla (\[ATR\]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | 255 |
| CBV+EFV Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine + zidovudine \[150 mg/300 mg\]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.
At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | 254 |
| Total | 509 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Atripla Phase | Adverse Event | 2 | 1 |
| Atripla Phase | Death | 0 | 2 |
| Atripla Phase | Lost to Follow-up | 5 | 7 |
| Atripla Phase | Non-compliance | 1 | 0 |
| Atripla Phase | Other | 3 | 1 |
| Atripla Phase | Pregnancy | 0 | 1 |
| Atripla Phase | Sub-optimal virological response | 0 | 1 |
| Atripla Phase | Withdrew consent | 7 | 7 |
| Randomized Phase | Adverse Event | 10 | 10 |
| Randomized Phase | Baseline NNRTI resistance mutations | 4 | 0 |
| Randomized Phase | Death | 1 | 3 |
| Randomized Phase | Hepatitis C treatment contraindicated | 0 | 1 |
| Randomized Phase | High Hepatitis B DNA | 0 | 1 |
| Randomized Phase | Inability to swallow pills | 0 | 1 |
| Randomized Phase | Incarceration | 3 | 2 |
| Randomized Phase | Lost to Follow-up | 26 | 33 |
| Randomized Phase | Moved out of State | 0 | 1 |
| Randomized Phase | Noncompliance | 8 | 4 |
| Randomized Phase | Pregnancy | 3 | 1 |
| Randomized Phase | Protocol Violation | 2 | 0 |
| Randomized Phase | Sub-optimal virological response | 3 | 13 |
| Randomized Phase | Withrawal of consent | 10 | 18 |
Baseline characteristics
| Characteristic | EFV+FTC+TDF | Total | CBV+EFV |
|---|---|---|---|
| Age Continuous | 38 years STANDARD_DEVIATION 9.9 | 38 years STANDARD_DEVIATION 9.5 | 38 years STANDARD_DEVIATION 9 |
| CD4 cell count | 246 Cells/mm^3 STANDARD_DEVIATION 171.9 | 245 Cells/mm^3 STANDARD_DEVIATION 164.2 | 245 Cells/mm^3 STANDARD_DEVIATION 156.6 |
| HIV-1 RNA | 5.03 Log10 c/mL STANDARD_DEVIATION 0.54 | 5.01 Log10 c/mL STANDARD_DEVIATION 0.52 | 5.00 Log10 c/mL STANDARD_DEVIATION 0.51 |
| HIV Status AIDS | 105 Participants | 206 Participants | 101 Participants |
| HIV Status Asymptomatic | 33 Participants | 59 Participants | 26 Participants |
| HIV Status Symptomatic HIV Infection | 117 Participants | 244 Participants | 127 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 65 Participants | 116 Participants | 51 Participants |
| Race/Ethnicity, Customized Hispanic | 39 Participants | 79 Participants | 40 Participants |
| Race/Ethnicity, Customized Not allowed to report | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 142 Participants | 298 Participants | 156 Participants |
| Sex: Female, Male Female | 36 Participants | 69 Participants | 33 Participants |
| Sex: Female, Male Male | 219 Participants | 440 Participants | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 233 / 257 | 152 / 160 | 222 / 254 | 190 / 286 |
| serious Total, serious adverse events | 29 / 257 | 24 / 160 | 35 / 254 | 14 / 286 |
Outcome results
Primary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 48 visit.
Time frame: 48 weeks
Population: Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline \[MITT analysis set: 487\])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm | 84.4 Percentage of participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm | 72.8 Percentage of participants |
Comparison: Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.00295% CI: [4.3, 18.6]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value
Time frame: Study/Atripla baseline to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) | 346 CD4 Cell count (Cells/mm^3) | Standard Deviation 197.2 |
| CBV+EFV | Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) | 42 CD4 Cell count (Cells/mm^3) | Standard Deviation 148.2 |
Secondary
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value
Time frame: Baseline to Week 144
Population: AT analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 | 312 CD4 Cell Count (cells/mm^3) | Standard Deviation 161.2 |
| CBV+EFV | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 | 271 CD4 Cell Count (cells/mm^3) | Standard Deviation 147.4 |
Comparison: Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.08995% CI: [4.05, 78.55]Van Elteren
Secondary
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value
Time frame: Study baseline to Week 48
Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 | 190 CD4 Cell Count (cells/mm^3) | Standard Deviation 111.7 |
| CBV+EFV | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 | 158 CD4 Cell Count (cells/mm^3) | Standard Deviation 107.3 |
Comparison: Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.00295% CI: [8.96, 54.52]Van Elteren
Secondary
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value
Time frame: Baseline to Week 96
Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 | 270 CD4 Cell Count (cells/mm^3) | Standard Deviation 147.5 |
| CBV+EFV | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 | 237 CD4 Cell Count (cells/mm^3) | Standard Deviation 136.4 |
Comparison: Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.03695% CI: [0.87, 64.99]Van Elteren
Secondary
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time frame: Study baseline to Week 144
Population: AT analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 | -3.32 Log10 c/mL | Standard Deviation 0.54 |
| CBV+EFV | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 | -3.30 Log10 c/mL | Standard Deviation 0.52 |
Comparison: Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.3995% CI: [-0.16, 0.08]Van Elteren
Secondary
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time frame: Study baseline to Week 48
Population: As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 | -3.31 Log10 c/mL | Standard Deviation 0.54 |
| CBV+EFV | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 | -3.26 Log10 c/mL | Standard Deviation 0.58 |
Comparison: Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.3195% CI: [-0.16, 0.06]Van Elteren
Secondary
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time frame: Study baseline to Week 96
Population: AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 | -3.30 Log10 c/mL | Standard Deviation 0.57 |
| CBV+EFV | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 | -3.25 Log10 c/mL | Standard Deviation 0.59 |
Comparison: Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.4595% CI: [-0.17, 0.08]Van Elteren
Secondary
Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | 0.12 limb fat (kg) | Standard Deviation 1.657 |
Comparison: Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.p-value: 0.16Wilcoxon Signed Rank test
Secondary
Change in Limb Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value
Time frame: Week 48 to Week 144
Population: ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Limb Fat (kg) From Week 48 to Week 144 | 1.13 limb fat (kg) | Standard Deviation 1.93 |
| CBV+EFV | Change in Limb Fat (kg) From Week 48 to Week 144 | -1.09 limb fat (kg) | Standard Deviation 1.72 |
Comparison: Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.001Wilcoxon Rank Sum test
Secondary
Change in Limb Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.
Time frame: Week 48 to Week 96
Population: ITT (whole body dual-energy X-ray absorptiometry \[DEXA\] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Limb Fat (kg) From Week 48 to Week 96 | 0.74 limb fat (kg) | Standard Deviation 1.6 |
| CBV+EFV | Change in Limb Fat (kg) From Week 48 to Week 96 | -0.77 limb fat (kg) | Standard Deviation 1.58 |
Comparison: Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equalp-value: <0.001Wilcoxon Rank Sum Test
Secondary
Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | 0.37 total body fat (kg) | Standard Deviation 3.747 |
Comparison: Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.p-value: 0.055Wilcoxon Signed Rank test
Secondary
Change in Total Body Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value
Time frame: Week 48 to Week 144
Population: ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Total Body Fat (kg) From Week 48 to Week 144 | 2.47 total body fat (kg) | Standard Deviation 4.22 |
| CBV+EFV | Change in Total Body Fat (kg) From Week 48 to Week 144 | -1.18 total body fat (kg) | Standard Deviation 3.37 |
Comparison: Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: <0.001Wilcoxon Rank Sum test
Secondary
Change in Total Body Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value
Time frame: 48 weeks to 96 weeks
Population: ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Total Body Fat (kg) From Week 48 to Week 96 | 1.69 total body fat (kg) | Standard Deviation 3.8 |
| CBV+EFV | Change in Total Body Fat (kg) From Week 48 to Week 96 | -0.82 total body fat (kg) | Standard Deviation 3.01 |
Comparison: Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: <0.001Wilcoxon Rank Sum test
Secondary
Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | 0.27 trunk fat (kg) | Standard Deviation 2.242 |
Comparison: Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.p-value: 0.049Wilcoxon Signed Rank test
Secondary
Change in Trunk Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value
Time frame: Week 48 to Week 144
Population: ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Trunk Fat (kg) From Week 48 to Week 144 | 1.30 trunk fat (kg) | Standard Deviation 2.4 |
| CBV+EFV | Change in Trunk Fat (kg) From Week 48 to Week 144 | -0.10 trunk fat (kg) | Standard Deviation 1.79 |
Comparison: Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.011Wilcoxon Rank Sum test
Secondary
Change in Trunk Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value
Time frame: Week 48 to Week 96
Population: ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Change in Trunk Fat (kg) From Week 48 to Week 96 | 0.94 trunk fat (kg) | Standard Deviation 2.3 |
| CBV+EFV | Change in Trunk Fat (kg) From Week 48 to Week 96 | -0.04 trunk fat (kg) | Standard Deviation 1.65 |
Comparison: Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.025Wilcoxon Rank Sum test
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV-1 RNA levels \< 400 c/mL prior to Week 144 visit.
Time frame: 144 weeks
Population: Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set \[Week 144 efficacy analysis set: 456).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | 70.9 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | 58.1 Percentage of Participants |
Comparison: Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.00495% CI: [4.2, 21.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 240 visit.
Time frame: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | 87 Percentage of Participants |
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 96 visit.
Time frame: 96 Weeks
Population: Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: \[463\])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | 74.6 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | 61.9 Percentage of Participants |
Comparison: Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.00495% CI: [4.3, 21.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV-1 RNA levels \< 50 c/mL prior to Week 144 visit.
Time frame: Week 144
Population: Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set \[Week 144 efficacy analysis set: 458).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | 64.3 Percentage of participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | 56.3 Percentage of participants |
Comparison: Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.08295% CI: [-0.8, 17]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 240 visit.
Time frame: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | 85 Percentage of Participants |
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 48 visit.
Time frame: Week 48
Population: MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline \[MITT analysis set: 487\])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) | 79.5 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) | 70.4 Percentage of Participants |
Comparison: Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.02195% CI: [1.6, 16.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA \< 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA \< 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA \< 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA \> 50 c/mL after achievement of confirmed HIV RNA levels \< 50 c/mL prior to Week 96 visit.
Time frame: Week 96
Population: Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: \[465\])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | 67.2 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | 60.9 Percentage of Participants |
Comparison: Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.p-value: 0.15895% CI: [-2.3, 15]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: 48 Weeks
Population: ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start \[ITT analysis set: 509\]).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 | 74.5 Percentage of Participants |
| CBV+EFV | Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 | 66.9 Percentage of Participants |
Comparison: Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.p-value: 0.05895% CI: [0.1, 15.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Week 144
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 | 28 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 | 41 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.003Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Baseline to 48 weeks
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 | 19 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 | 30 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.p-value: 0.003Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA \< 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA \> 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.
Time frame: Week 96
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 | 25 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 | 37 Percentage of Participants |
Comparison: Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.003Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | 13 Percentage of Participants |
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Week 144
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 | 34 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 | 43 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.056Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Baseline to 48 Weeks
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 | 23 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 | 32 Percentage of Participants |
Comparison: Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.p-value: 0.046Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Week 96
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 | 32 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 | 38 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.124Log Rank
Secondary
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1.
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | 15 Percentage of Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: Week 144
Population: ITT Analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 | 63.1 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 | 51.6 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.p-value: 0.00995% CI: [3.1, 20.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) | 87 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) | 85 Percentage of Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
The percentage of participants with plasma HIV-1 RNA \< 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: 48 weeks
Population: Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start \[ITT analysis set: 509\]).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. | 80.4 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. | 69.3 Percentage of Participants |
Comparison: Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.p-value: 0.00495% CI: [3.7, 18.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: Week 144
Population: ITT Analysis set (Missing Observation or Switch in ART=Failure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 | 60.8 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 | 50.4 Percentage of Participants |
Comparison: Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.p-value: 0.01995% CI: [1.8, 19]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA \< 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time frame: Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) | 84 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) | 82 Percentage of Participants |
Secondary
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 144
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 | 11 Percentage of participants |
| CBV+EFV | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 | 17 Percentage of participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groupsp-value: 0.066Log Rank
Secondary
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 240 (Atripla Week 96)
Population: MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) | 11 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) | 2 Percentage of Participants |
Secondary
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 144
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 | 21 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 | 25 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groupsp-value: 0.3Log Rank
Secondary
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 240 (Atripla Week 96)
Population: MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) | 22 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) | 4 Percentage of Participants |
Secondary
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Baseline to 48 Weeks
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 | 9 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 | 16 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.p-value: 0.026Log Rank
Secondary
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA \< 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 96
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 | 9 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 | 17 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.p-value: 0.025Log Rank
Secondary
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Baseline to 48 Weeks
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 | 16 Percentage of participants |
| CBV+EFV | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 | 24 Percentage of participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.p-value: 0.063Log Rank
Secondary
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA \< 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time frame: Week 96
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EFV+FTC+TDF | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 | 20 Percentage of Participants |
| CBV+EFV | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 | 23 Percentage of Participants |
Comparison: Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are differentp-value: 0.41Log Rank
Secondary
Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | 0.9 Composite Score | Standard Deviation 8.65 |
Comparison: Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.23Wilcoxon Signed Rank Test
Secondary
Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).
Time frame: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EFV+FTC+TDF | Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | 0.0 Composite Score | Standard Deviation 6.8 |
Comparison: Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.95Wilcoxon Signed Rank Test
Secondary
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly).
Time frame: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Bothers me (W 144 and W 240) | 41 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Does not bother me (W 144 and W 240) | 126 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Bothers me (W 144); does not bother me (W 240) | 31 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Does not bother me (W 144); bothers me (W 240) | 28 Participants |
Comparison: Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.7McNemar
Secondary
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied).
Time frame: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144 and W 240) | 180 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144 and W 240) | 10 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144); not very satisfied (W 240) | 9 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144); very satisfied (W 240) | 23 Participants |
Comparison: Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.013McNemar
Secondary
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied).
Time frame: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144 and W 240) | 182 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144 and W 240) | 6 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144); not very satisfied (W 240) | 8 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144); very satisfied (W 240) | 29 Participants |
Comparison: Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: <0.001McNemar
Secondary
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied).
Time frame: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144 and W 240) | 192 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144 and W 240) | 8 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144); not very satisfied (W 240) | 9 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144); very satisfied (W 240) | 17 Participants |
Comparison: Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.12McNemar
Secondary
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied).
Time frame: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Population: Atripla Efficacy Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144 and W 240) | 166 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144 and W 240) | 21 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Very satisfied (W 144); not very satisfied (W 240) | 13 Participants |
| EFV+FTC+TDF | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Not very satisfied (W 144); very satisfied (W 240) | 26 Participants |
Comparison: Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).p-value: 0.037McNemar