HIV Infections
Conditions
Keywords
Treatment Naive, Adherence, Drug Resistance, Treatment Failure
Brief summary
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
Detailed description
In developed countries, standard effective antiretroviral (ARV) therapy for treatment-naive HIV infected people includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). However, direct comparisons of ARV efficacy in persons that more closely reflect the worldwide demographics of HIV-1 infection are needed.\> \> Trial participants were recruited in Africa (Malawi, South Africa, Zimbabwe), Asia (India, Thailand), South America (Brazil, Peru), Haiti, and the United States.\> \> All participants were randomly assigned to one of three arms, and random allocation was stratified by 2 factors: country, and screening plasma HIV-1 RNA level (\< 100,000 copies/mL versus \>= 100,000 copies/mL). Participants assigned to the ZDV/3TC+EFV arm received lamivudine/zidovudine twice daily and efavirenz once daily. Participants assigned to the ddI+FTC+ATV arm received emtricitabine, atazanavir, and enteric-coated didanosine once daily. Participants assigned to the TDF/FTC+EFV arm received emtricitabine, tenofovir disoproxil fumarate, and efavirenz once daily. \> \> \> Physical exam and blood collection occurred at entry and at most study visits. Participants experiencing virologic failure were offered a switch to another regimen. \> \> On May 23, 2008, the ddI+FTC+ATV was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that this arm had significantly more virologic failure (and therefore was inferior when) compared to the ZDV/3TC+EFV arm . Participants still receiving ddI+FTC+ATV were offered alternative medications, and all participants continued to be followed. \> \> On November 3, 2009, the DSMB recommended that the study close to all follow-up on May 31, 2010, before the designed termination (based on 30% of participants meeting the primary outcome) was met. The board observed that the recent accumulation of primary efficacy events (i.e. regimen failures) was very slow. Therefore, if the study were to continue another 1-2 years, the precision gained for treatment comparisons would likely be small.
Interventions
DRUGAtazanavir
400 mg taken orally daily
DRUGDidanosine (enteric-coated)
400 mg taken orally daily
DRUGEfavirenz
600 mg taken orally daily
DRUGEmtricitabine
200 mg taken orally daily
DRUGEmtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
DRUGLamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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
:\> * HIV-1 infected\> * CD4 count fewer than 300 cells/mm3 \> * Viral load test result\> * Absolute Neutrophil Count at least 750mm3 \> * Hemoglobin at least 7.5 g/dL\> * Platelet count at least 50,000/mm3\> * Calculated creatinine clearance at least 60 mL/min\> * A , A, and alkaline phosphatase \<= 5 times upper limit of normal\> * total bilirubin \<= 2.5 times upper limit of normal\> * Karnofsky performance score of 70 or higher\> * Plans to stay in the area for the duration of the study\> * Agrees to use acceptable forms of contraception for the duration of the study\>
Exclusion criteria
\> * More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period for the purpose of pMTCT)\> * Acute therapy for serious medical illnesses within 14 days prior to study entry\> * Certain abnormal laboratory values\> * Radiation therapy or chemotherapy within 45 days prior to study entry. \> * Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. \> * Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation\> * Inflamed pancreas within 3 years prior to study entry\> * Allergy/sensitivity to any of the study drugs or their formulations\> * Heart rate less than 40 beats/min\> * History of untreated, active second- or third-degree heart block\> * Currently detained in jail or for treatment of a psychiatric or physical illness\> * Vomiting or inability to swallow medications\> * Pregnancy\>
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure (PI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008). | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). |
| Time to Treatment Failure (NRTI Comparison) | Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010). | Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). |
| Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. |
| Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. |
| Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | Throughout follow-up until study closed (May 31,2010) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). |
| Time to Immunologic Failure (NRTI Comparison) | At or after Week 48 (including all follow-up through study closure - May 31,2010) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. |
| Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) | Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). |
| Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010) | Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Week 48 (using follow-up through study closure on May 31,2010) | Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | Week 96 (using follow-up through to study closure on May 31,2010) | Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Week 48 using follow-up through study closure on May 31,2010 | Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | Week 96 using follow-up through study closure on May 31,2010 | Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression. |
| Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | Throughout study follow-up until study closure (May 31, 2010) | Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. |
| Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010) | Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). |
| Time to Immunologic Failure (PI Comparison) | At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) | Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. |
Countries
Brazil, Haiti, India, Malawi, Peru, South Africa, Thailand, United States, Zimbabwe
Participant flow
Recruitment details
Study participants were recruited at 43 sites from 9 countries: 28 in the US, 4 in India, 2 each in Brazil, Malawi, Peru and South Africa, and 1 each in Haiti, Thailand and Zimbabwe, between May 2005 to August 2007.
Pre-assignment details
HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count \<300 cells/mm\^3.
Participants by arm
| Arm | Count |
|---|---|
| ZDV/3TC+EFV ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz | 519 |
| ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine \>
\> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed. | 526 |
| TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz | 526 |
| Total | 1,571 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| NRTI Comparison | Clinic site closed | 12 | 0 | 14 |
| NRTI Comparison | Death | 20 | 0 | 18 |
| NRTI Comparison | Lost to Follow-up | 14 | 0 | 12 |
| NRTI Comparison | Not reason above | 1 | 0 | 0 |
| NRTI Comparison | Withdrawal by Subject | 54 | 0 | 38 |
| PI Comparison | Clinic site closed | 1 | 0 | 0 |
| PI Comparison | Death | 10 | 9 | 0 |
| PI Comparison | Lost to Follow-up | 11 | 8 | 0 |
| PI Comparison | Withdrawal by Subject | 33 | 30 | 0 |
Baseline characteristics
| Characteristic | ZDV/3TC+EFV | ddI+FTC+ATV | TDF/FTC+EFV | Total |
|---|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 8 | 35 years STANDARD_DEVIATION 9 | 35 years STANDARD_DEVIATION 9 |
| Age, Customized At least 50 years | 34 participants | 30 participants | 39 participants | 103 participants |
| Age, Customized Between 18 and 29 years | 141 participants | 146 participants | 146 participants | 433 participants |
| Age, Customized Between 30 and 39 years | 244 participants | 221 participants | 225 participants | 690 participants |
| Age, Customized Between 40 and 49 years | 100 participants | 129 participants | 116 participants | 345 participants |
| CD4 count, Categorical < 50 cells/mm^3 | 68 participants | 63 participants | 69 participants | 200 participants |
| CD4 count, Categorical Between 100 and 199 cells/mm^3 | 174 participants | 161 participants | 193 participants | 528 participants |
| CD4 count, Categorical Between 200 and 249 cells/mm^3 | 104 participants | 128 participants | 107 participants | 339 participants |
| CD4 count, Categorical Between 250 and 299 cells/mm^3 | 103 participants | 97 participants | 75 participants | 275 participants |
| CD4 count, Categorical Between 50 and 99 cells/mm^3 | 70 participants | 77 participants | 82 participants | 229 participants |
| CD4 count, Continuous | 163 cells/mm^3 STANDARD_DEVIATION 85 | 167 cells/mm^3 STANDARD_DEVIATION 83 | 155 cells/mm^3 STANDARD_DEVIATION 81 | 162 cells/mm^3 STANDARD_DEVIATION 83 |
| Plasma HIV-1 RNA, Categorical <= 400 copies/mL | 3 participants | 6 participants | 3 participants | 12 participants |
| Plasma HIV-1 RNA, Categorical >= 750,000 copies/mL | 35 participants | 40 participants | 46 participants | 121 participants |
| Plasma HIV-1 RNA, Categorical Between 400,001 and 749,999 copies/mL | 45 participants | 58 participants | 55 participants | 158 participants |
| Plasma HIV-1 RNA, Categorical Between 40,001 and 400,000 copies/mL | 311 participants | 283 participants | 284 participants | 878 participants |
| Plasma HIV-1 RNA, Categorical Between 4001 and 40,000 copies/mL | 103 participants | 119 participants | 124 participants | 346 participants |
| Plasma HIV-1 RNA, Categorical Between 400 and 4000 copies/mL | 22 participants | 19 participants | 14 participants | 55 participants |
| Plasma HIV-1 RNA, Categorical Missing | 0 participants | 1 participants | 0 participants | 1 participants |
| Plasma HIV-1 RNA, Continuous | 5.0 log10 copies/mL | 5.1 log10 copies/mL | 5.0 log10 copies/mL | 5.0 log10 copies/mL |
| Region of Enrollment Brazil | 79 participants | 76 participants | 76 participants | 231 participants |
| Region of Enrollment Haiti | 35 participants | 32 participants | 33 participants | 100 participants |
| Region of Enrollment India | 81 participants | 86 participants | 88 participants | 255 participants |
| Region of Enrollment Malawi | 74 participants | 74 participants | 73 participants | 221 participants |
| Region of Enrollment Peru | 42 participants | 48 participants | 44 participants | 134 participants |
| Region of Enrollment South Africa | 70 participants | 70 participants | 70 participants | 210 participants |
| Region of Enrollment Thailand | 32 participants | 33 participants | 35 participants | 100 participants |
| Region of Enrollment United States | 70 participants | 70 participants | 70 participants | 210 participants |
| Region of Enrollment Zimbabwe | 36 participants | 37 participants | 37 participants | 110 participants |
| Sex: Female, Male Female | 241 Participants | 256 Participants | 242 Participants | 739 Participants |
| Sex: Female, Male Male | 278 Participants | 270 Participants | 284 Participants | 832 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 481 / 519 | 521 / 526 | 489 / 526 |
| serious Total, serious adverse events | 86 / 519 | 84 / 526 | 55 / 526 |
Outcome results
Primary
Time to Treatment Failure (NRTI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).
Time frame: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
Population: ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Treatment Failure (NRTI Comparison) | 5th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Treatment Failure (NRTI Comparison) | 10th percentile | 40 weeks |
| ZDV/3TC+EFV | Time to Treatment Failure (NRTI Comparison) | 25th percentile | NA weeks |
| TDF/FTC+EFV | Time to Treatment Failure (NRTI Comparison) | 5th percentile | 16 weeks |
| TDF/FTC+EFV | Time to Treatment Failure (NRTI Comparison) | 10th percentile | 40 weeks |
| TDF/FTC+EFV | Time to Treatment Failure (NRTI Comparison) | 25th percentile | NA weeks |
Comparison: While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.95% CI: [0.72, 1.27]Other
Primary
Time to Treatment Failure (PI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).
Time frame: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
Population: ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Treatment Failure (PI Comparison) | 5th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Treatment Failure (PI Comparison) | 10th percentile | 40 weeks |
| ZDV/3TC+EFV | Time to Treatment Failure (PI Comparison) | 25th percentile | NA weeks |
| ddI+FTC+ATV | Time to Treatment Failure (PI Comparison) | 5th percentile | 16 weeks |
| ddI+FTC+ATV | Time to Treatment Failure (PI Comparison) | 10th percentile | 24 weeks |
| ddI+FTC+ATV | Time to Treatment Failure (PI Comparison) | 25th percentile | 120 weeks |
p-value: <0.0195% CI: [1.12, 2.04]Log Rank
Secondary
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).
Time frame: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
Population: ITT - ignoring both current treatment status and treatment history.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 24 (N=490; N=498) | 112.5 cells/mm^3 |
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 48 (N=480; N=485) | 151.5 cells/mm^3 |
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 96 (N=458; N=471) | 220.5 cells/mm^3 |
| TDF/FTC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 96 (N=458; N=471) | 226 cells/mm^3 |
| TDF/FTC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 24 (N=490; N=498) | 120.5 cells/mm^3 |
| TDF/FTC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) | Change from screening to week 48 (N=480; N=485) | 159 cells/mm^3 |
Secondary
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).
Time frame: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Population: ITT - ignoring both current treatment status and treatment history.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 24 (N=490; N=502) | 112.5 cells/mm^3 |
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 48 (N=474; N=477) | 152.0 cells/mm^3 |
| ZDV/3TC+EFV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 96 (N= 188; N=188) | 216.0 cells/mm^3 |
| ddI+FTC+ATV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 24 (N=490; N=502) | 146.5 cells/mm^3 |
| ddI+FTC+ATV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 48 (N=474; N=477) | 187.0 cells/mm^3 |
| ddI+FTC+ATV | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) | Change from screening to week 96 (N= 188; N=188) | 256.0 cells/mm^3 |
Secondary
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.
Time frame: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
Population: ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Week 24: Number with RNA <400 c/mL (N=495; N=500) | 459 participants |
| ZDV/3TC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Week 48: Number with RNA <400 c/mL (N=482; N=487) | 442 participants |
| TDF/FTC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Week 24: Number with RNA <400 c/mL (N=495; N=500) | 448 participants |
| TDF/FTC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) | Week 48: Number with RNA <400 c/mL (N=482; N=487) | 455 participants |
Secondary
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.
Time frame: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Population: ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Week 24: Number with RNA <400 c/mL (N=495; N=506) | 459 participants |
| ZDV/3TC+EFV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Week 48: Number with RNA <400 c/mL (N=476; N=478) | 437 participants |
| ddI+FTC+ATV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Week 24: Number with RNA <400 c/mL (N=495; N=506) | 431 participants |
| ddI+FTC+ATV | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) | Week 48: Number with RNA <400 c/mL (N=476; N=478) | 424 participants |
Secondary
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).
Time frame: Throughout follow-up until study closed (May 31,2010)
Population: Participants not starting study treatment excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 5th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 10th percentile | 34 weeks |
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 25th percentile | 163 weeks |
| TDF/FTC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 5th percentile | 18 weeks |
| TDF/FTC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 10th percentile | 36 weeks |
| TDF/FTC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) | 25th percentile | 201 weeks |
Secondary
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).
Time frame: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
Population: Participants not starting study treatment excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 5th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 10th percentile | 34 weeks |
| ZDV/3TC+EFV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 25th percentile | NA weeks |
| ddI+FTC+ATV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 5th percentile | 7 weeks |
| ddI+FTC+ATV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 10th percentile | 18 weeks |
| ddI+FTC+ATV | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) | 25th percentile | 76 weeks |
Secondary
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time frame: Throughout study follow-up until study closure (May 31, 2010)
Population: Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 10th percentile | 4 weeks |
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 25th percentile | 12 weeks |
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 50th percentile | 112 weeks |
| TDF/FTC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 10th percentile | 4 weeks |
| TDF/FTC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 25th percentile | 32 weeks |
| TDF/FTC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) | 50th percentile | 224 weeks |
Secondary
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time frame: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
Population: Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 10th percentile | 4 weeks |
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 25th percentile | 12 weeks |
| ZDV/3TC+EFV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 50th percentile | 96 weeks |
| ddI+FTC+ATV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 10th percentile | 4 weeks |
| ddI+FTC+ATV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 25th percentile | 32 weeks |
| ddI+FTC+ATV | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) | 50th percentile | 144 weeks |
Secondary
Time to Immunologic Failure (NRTI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
Time frame: At or after Week 48 (including all follow-up through study closure - May 31,2010)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Immunologic Failure (NRTI Comparison) | 1st percentile | 48 weeks |
| ZDV/3TC+EFV | Time to Immunologic Failure (NRTI Comparison) | 5th percentile | 128 weeks |
| ZDV/3TC+EFV | Time to Immunologic Failure (NRTI Comparison) | 10th percentile | NA weeks |
| TDF/FTC+EFV | Time to Immunologic Failure (NRTI Comparison) | 1st percentile | 48 weeks |
| TDF/FTC+EFV | Time to Immunologic Failure (NRTI Comparison) | 5th percentile | 104 weeks |
| TDF/FTC+EFV | Time to Immunologic Failure (NRTI Comparison) | 10th percentile | NA weeks |
Secondary
Time to Immunologic Failure (PI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
Time frame: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
Population: ITT (ignoring current study treatment status or history)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Immunologic Failure (PI Comparison) | 1st percentile | 48 weeks |
| ZDV/3TC+EFV | Time to Immunologic Failure (PI Comparison) | 5th percentile | 112 weeks |
| ddI+FTC+ATV | Time to Immunologic Failure (PI Comparison) | 1st percentile | 48 weeks |
| ddI+FTC+ATV | Time to Immunologic Failure (PI Comparison) | 5th percentile | NA weeks |
Secondary
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 48 (using follow-up through study closure on May 31,2010)
Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 10th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 10th percentile | 24 weeks |
Secondary
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 48 using follow-up through study closure on May 31,2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 10th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 25th percentile | 32 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 10th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 25th percentile | NA weeks |
Secondary
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 5th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 10th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 25th percentile | 32 weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 5th percentile | 0 weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 10th percentile | 0 weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) | 25th percentile | 48 weeks |
Secondary
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 96 (using follow-up through to study closure on May 31,2010)
Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 10th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 25th percentile | NA weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 25th percentile | NA weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) | 10th percentile | 24 weeks |
Secondary
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 96 using follow-up through study closure on May 31,2010
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 10th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 25th percentile | 32 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 5th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 10th percentile | 0 weeks |
| TDF/FTC+EFV | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) | 25th percentile | NA weeks |
Secondary
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.
Time frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZDV/3TC+EFV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 5th percentile | 0 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 10th percentile | 16 weeks |
| ZDV/3TC+EFV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 25th percentile | NA weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 10th percentile | 0 weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 5th percentile | 0 weeks |
| ddI+FTC+ATV | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) | 25th percentile | 48 weeks |