HIV Infection
Conditions
Keywords
HEAT, Antiretroviral-naive, HIV, EPZICOM, TRUVADA, KALETRA, once-daily
Brief summary
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks
Interventions
The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males as females at least 18 years old. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.) * Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI). * Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening. * Subject is willing and able to understand and provide written informed consent prior to participation in this study.
Exclusion criteria
* Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed at least 30 days prior to screening. * Subject is enrolled in one or more investigational drug protocols, which may impact HIV-1 RNA suppression. * Subject is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments. * Subject is either pregnant or breastfeeding. * Subject has an ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening. * Subject suffers from a serious medical condition, such as cirrhosis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject. * Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments. * Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction which may interfere with drug absorption or render the subject unable to take oral medication. * Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, precludes the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality will exclude a subject from study participation. * Subject has estimated creatinine clearance \<50 mL/min via Cockroft-Gault method. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN). * Subject has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period. * Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to Screen. Asthmatic subjects using inhaled corticosteroids are eligible for enrollment. * Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration. * Subjects who require treatment with the prohibited medications within 28 days of commencement of investigational product, or an anticipated need during the study. * Subject has a history of allergy to any of the study drugs or any excipients therein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. | Week 48 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 copies/mL and \>=100,000 copies/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Week 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL). |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL. |
| Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL). |
| Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL. |
| Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Week 48 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL). |
| Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 | Weeks 48 and 96 | A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline. |
| Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Baseline to Week 96 | The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA \<200 copies/mL or HIV-1 RNA rebound \>= 200 copies/mL on two consecutive occasions. |
| Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | Baseline and time of virologic failure (up to Week 96) | A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Baseline and time of virologic failure (up to Week 96) | A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class. |
| Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Baseline through 96 weeks | The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated. |
| Median Change From Baseline in HIV-1 RNA at Week 48 and 96 | Weeks 48 and 96 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.
Pre-assignment details
After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily | 343 |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily | 345 |
| Total | 688 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 20 | 21 |
| Overall Study | Lack of Compliance | 10 | 11 |
| Overall Study | Lost to Follow-up | 45 | 52 |
| Overall Study | Protocol-Defined Virologic Failure | 8 | 6 |
| Overall Study | Protocol Violation, disease progression | 13 | 11 |
| Overall Study | Withdrawal by Subject | 13 | 23 |
Baseline characteristics
| Characteristic | Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Total | Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) |
|---|---|---|---|
| Age Continuous | 38.7 years STANDARD_DEVIATION 9.55 | 38.3 years STANDARD_DEVIATION 9.68 | 38.0 years STANDARD_DEVIATION 9.8 |
| Baseline CD4+ Cell Count | 193 cells per cmm | 202 cells per cmm | 214 cells per cmm |
| Baseline CD4+ Cell Count Level >= 200 cells per cmm | 165 participants | 348 participants | 183 participants |
| Baseline CD4+ Cell Count Level 50 - <200 cells per cmm | 110 participants | 209 participants | 99 participants |
| Baseline CD4+ Cell Count Level <50 cells per cmm | 70 participants | 131 participants | 61 participants |
| Baseline HIV-1 RNA | 4.844 log10 copies/mL | 4.876 log10 copies/mL | 4.903 log10 copies/mL |
| Baseline HIV-1 RNA Level 100,000 - <250,000 copies/mL | 75 participants | 143 participants | 68 participants |
| Baseline HIV-1 RNA Level <100,000 copies/mL | 205 participants | 393 participants | 188 participants |
| Baseline HIV-1 RNA Level 250,000 - <500,000 copies/mL | 33 participants | 70 participants | 37 participants |
| Baseline HIV-1 RNA Level >=500,000 copies/mL | 32 participants | 82 participants | 50 participants |
| Centers for Disease Control (CDC) Classification A: Asymptomatic HIV infection | 240 participants | 469 participants | 229 participants |
| Centers for Disease Control (CDC) Classification B: Symptomatic HIV infection | 48 participants | 107 participants | 59 participants |
| Centers for Disease Control (CDC) Classification C: AIDS | 57 participants | 112 participants | 55 participants |
| Hepatitis B Infection Missing | 2 participants | 2 participants | 0 participants |
| Hepatitis B Infection Non-Reactive | 334 participants | 658 participants | 324 participants |
| Hepatitis B Infection Reactive | 9 participants | 28 participants | 19 participants |
| Hepatitis C Infection Missing | 2 participants | 2 participants | 0 participants |
| Hepatitis C Infection Non-Reactive | 319 participants | 635 participants | 316 participants |
| Hepatitis C Infection Reactive | 24 participants | 51 participants | 27 participants |
| Race/Ethnicity, Customized African American/African Heritage | 124 participants | 246 participants | 122 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 9 participants | 15 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 62 participants | 135 participants | 73 participants |
| Race/Ethnicity, Customized Missing Information | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 282 participants | 552 participants | 270 participants |
| Race/Ethnicity, Customized Unspecified | 36 participants | 72 participants | 36 participants |
| Race/Ethnicity, Customized White | 174 participants | 351 participants | 177 participants |
| Sex: Female, Male Female | 69 Participants | 125 Participants | 56 Participants |
| Sex: Female, Male Male | 276 Participants | 563 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 182 / — | 182 / — |
| serious Total, serious adverse events | 42 / — | 45 / — |
Outcome results
Primary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 copies/mL and \>=100,000 copies/mL).
Time frame: Week 48
Population: The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA \>=50 copies/mL.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. | 67.5 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. | 67.2 percentage of participants |
p-value: 0.91395% CI: [-6.63, 7.4]Cochran-Mantel-Haenszel
Secondary
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 | Week 48 | 201.0 cells per cmm |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 | Week 96 | 250.0 cells per cmm |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 | Week 48 | 173.0 cells per cmm |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 | Week 96 | 246.5 cells per cmm |
Secondary
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 | Week 96 | -3.114 log10 copies/mL |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 | Week 48 | -3.142 log10 copies/mL |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 | Week 48 | -3.131 log10 copies/mL |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 | Week 96 | -3.165 log10 copies/mL |
Secondary
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Time frame: Baseline and time of virologic failure (up to Week 96)
Population: Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184M/I | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184I | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184A/V | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V) | 11 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184V | 4 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to lamivudine/M184M/I/V | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/V | 3 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184V | 4 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/I | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184I | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced phen susceptibility to lamivudine/M184M/V | 3 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/I/V | 0 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184A/V | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/I/V | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184I | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/I | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V) | 17 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184V | 9 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced phen susceptibility to lamivudine/M184M/V | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184M/I | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to lamivudine/M184M/I/V | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184V | 9 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184M/V | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184A/V | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno suscept. to emtricitabine/M184I | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility | Reduced pheno susceptibility to lamivudine/M184A/V | 1 participants |
Secondary
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: Baseline and time of virologic failure (up to Week 96)
Population: Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | PI-associated mutations | 11 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | NRTI-associated mutations | 11 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | Participants with treatment-emergent mutations | 18 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | NNRTI-associated mutations | 4 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | No. with paired genotypes at baseline and wk 96 | 45 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | NNRTI-associated mutations | 3 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | No. with paired genotypes at baseline and wk 96 | 41 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | PI-associated mutations | 7 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | Participants with treatment-emergent mutations | 22 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks | NRTI-associated mutations | 17 participants |
Secondary
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA \<200 copies/mL or HIV-1 RNA rebound \>= 200 copies/mL on two consecutive occasions.
Time frame: Baseline to Week 96
Population: The Intent-To-Treat-Exposed (ITT-E) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Fail to confirm HIV-1 RNA <200 copies/mL by wk 24 | 21 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Confirmed HIV-1 RNA rebound to >= 200 copies/mL | 28 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Protocol-defined virologic failure | 49 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Suspected HIV-1 RNA rebound to >= 200 copies/mL | 12 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Suspected HIV-1 RNA rebound to >= 200 copies/mL | 11 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Fail to confirm HIV-1 RNA <200 copies/mL by wk 24 | 24 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Protocol-defined virologic failure | 48 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 | Confirmed HIV-1 RNA rebound to >= 200 copies/mL | 24 participants |
Secondary
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Time frame: Baseline through 96 weeks
Population: The Safety population which included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Participants (Par.) with suspected ABC HSR | 14 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Mild or Grade 1 | 1 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Moderate or Grade 2 | 8 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Severe or Grade 3 | 4 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Not Applicable | 1 participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Par. with proximal renal tubule dysfunction | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Not Applicable | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Participants (Par.) with suspected ABC HSR | 3 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Severe or Grade 3 | 1 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Mild or Grade 1 | 0 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Par. with proximal renal tubule dysfunction | 5 participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction | Moderate or Grade 2 | 2 participants |
Secondary
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M=F, Switch Included, Week 48 | 75.2 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | TLOVR, Week 48 | 70.9 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | Obs, Week 96 | 92.8 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M/D=F, Week 96 | 60.1 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | Obs, Week 48 | 93.8 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M/D=F, Week 48 | 71.4 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M=F, Switch Included, Week 96 | 63.9 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | TLOVR, Week 96 | 58.4 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | TLOVR, Week 96 | 56.3 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M=F, Switch Included, Week 48 | 71.3 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | Obs, Week 48 | 92.2 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M=F, Switch Included, Week 96 | 61.2 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | Obs, Week 96 | 96.3 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M/D=F, Week 48 | 66.2 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | M/D=F, Week 96 | 56.9 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 | TLOVR, Week 48 | 66.4 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 48 | 76 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 48 | 72 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 48 | 94 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M/D=F, Week 48 | 72 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 96 | 65 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 96 | 60 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 96 | 92 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M/D=F, Week 96 | 61 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M/D=F, Week 96 | 56 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 48 | 71 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 96 | 60 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 48 | 66 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 96 | 97 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 48 | 91 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 96 | 55 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M/D=F, Week 48 | 65 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 48 | 94 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 48 | 75 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 48 | 71 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 96 | 63 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 96 | 93 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 48 | 70 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 96 | 59 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 96 | 56 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 96 | 58 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 96 | 63 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 48 | 71 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 48 | 67 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 48 | 94 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 96 | 58 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 96 | 96 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 48 | 68 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Time frame: Week 48
Population: The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | TLOVR | 62.6 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Obs | 84.3 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | M/D=F | 64.3 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | TLOVR | 61.1 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Obs | 86.8 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | M/D=F | 62.3 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Time frame: Week 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | TLOVR | 52.1 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Obs | 86.9 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | M/D=F | 56.4 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | M=F, Switch Included | 59.9 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | M=F, Switch Included | 58.0 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | TLOVR | 51.0 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | M/D=F | 54.5 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Obs | 91.3 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 48 | 67 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 96 | 63 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 48 | 89 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | MD=F, Week 96 | 59 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | MD=F, Week 48 | 68 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 96 | 57 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 48 | 71 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 96 | 89 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | MD=F, Week 96 | 54 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 96 | 58 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 96 | 94 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | M=F, Switch Included, Week 48 | 69 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 48 | 62 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | Obs, Week 48 | 88 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | TLOVR, Week 96 | 52 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL | MD=F, Week 48 | 62 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL.
Time frame: Weeks 48 and 96
Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 48 | 59 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 96 | 56 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 48 | 63 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 48 | 57 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 48 | 78 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 96 | 46 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 96 | 84 percentage of participants |
| Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 96 | 54 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 48 | 60 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 48 | 62 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | TLOVR, Week 96 | 51 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 96 | 58 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M/D=F, Week 96 | 55 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 48 | 86 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | M=F, Switch Included, Week 48 | 65 percentage of participants |
| Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL | Obs, Week 96 | 88 percentage of participants |