| Primary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm | Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit. | Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487]) | Posted | | Number | | Percentage of participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group. Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group. | Cochran-Mantel-Haenszel | No other adjustments were made. | 0.002 | The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count. | Difference in percentages | 11.4 | | | 2-Sided | 95 | 4.3 | 18.6 | |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) | Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit. | MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487]) | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. | The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). | Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]). | Posted | | Number | | Percentage of Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 | The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). | ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]). | Posted | | Number | | Percentage of Participants | | 48 Weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Baseline to 48 Weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 | Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of Participants | | Baseline to 48 Weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 | Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of participants | | Baseline to 48 Weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 | Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). | As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation. | Posted | | Mean | Standard Deviation | Log10 c/mL | | Study baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 | Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value | AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation. | Posted | | Mean | Standard Deviation | CD4 Cell Count (cells/mm^3) | | Study baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit. | Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463]) | Posted | | Number | | Percentage of Participants | | 96 Weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) | Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit. | Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465]) | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 | TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 | Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 | Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 | Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). | AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation. | Posted | | Mean | Standard Deviation | Log10 c/mL | | Study baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 | Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value | AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation. | Posted | | Mean | Standard Deviation | CD4 Cell Count (cells/mm^3) | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Change in Limb Fat (kg) From Week 48 to Week 96 | Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. | ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93) | Posted | | Mean | Standard Deviation | limb fat (kg) | | Week 48 to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Trunk Fat (kg) From Week 48 to Week 96 | Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value | ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93) | Posted | | Mean | Standard Deviation | trunk fat (kg) | | Week 48 to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Total Body Fat (kg) From Week 48 to Week 96 | Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value | ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93) | Posted | | Mean | Standard Deviation | total body fat (kg) | | 48 weeks to 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit. | Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).](streamdown:incomplete-link) | Posted | | Number | | Percentage of Participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) | Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit. | Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).](streamdown:incomplete-link) | Posted | | Number | | Percentage of participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 | The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). | | Posted | | Number | | Percentage of Participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 | The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). | ITT Analysis set (Missing Observation or Switch in ART=Failure) | Posted | | Number | | Percentage of Participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | | Posted | | Number | | Percentage of Participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 | Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 | Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | | Posted | | Number | | Percentage of Participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 | Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). | | Posted | | Mean | Standard Deviation | Log10 c/mL | | Study baseline to Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 | Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value | | Posted | | Mean | Standard Deviation | CD4 Cell Count (cells/mm^3) | | Baseline to Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Limb Fat (kg) From Week 48 to Week 144 | Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value | ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86) | Posted | | Mean | Standard Deviation | limb fat (kg) | | Week 48 to Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Trunk Fat (kg) From Week 48 to Week 144 | Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value | ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86) | Posted | | Mean | Standard Deviation | trunk fat (kg) | | Week 48 to Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity. At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Total Body Fat (kg) From Week 48 to Week 144 | Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value | ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86) | Posted | | Mean | Standard Deviation | total body fat (kg) | | Week 48 to Week 144 | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF | Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity. At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | CBV+EFV | |
|
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit. | Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set. | Posted | | Number | | Percentage of Participants | | Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm | Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit. | Atripla Efficacy Analysis Set | Posted | | Number | | Percentage of Participants | | Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) | The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). | Atripla Efficacy Analysis Set | Posted | | Number | | Percentage of Participants | | Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF/Atripla (From Study Baseline) | Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | All Atripla (From Atripla Baseline) | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) | The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). | Atripla Efficacy Analysis Set | Posted | | Number | | Percentage of Participants | | Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF/Atripla (From Study Baseline) | Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | All Atripla (From Atripla Baseline) | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | Atripla Efficacy Analysis Set | Posted | | Number | | Percentage of Participants | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) | TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered "non-responders" on Study Day 1. | Atripla Efficacy Analysis Set | Posted | | Number | | Percentage of Participants | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) | Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244). Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286) | Posted | | Number | | Percentage of Participants | | Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF/Atripla (From Study Baseline) | Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | All Atripla (From Atripla Baseline) | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) | Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. | MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244). Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286) | Posted | | Number | | Percentage of Participants | | Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF/Atripla (From Study Baseline) | Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | All Atripla (From Atripla Baseline) | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) | Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | CD4 Cell count (Cells/mm^3) | | Study/Atripla baseline to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | EFV+FTC+TDF/Atripla (From Study Baseline) | Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. | | OG001 | All Atripla (From Atripla Baseline) | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
|
| Secondary | Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | limb fat (kg) | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | trunk fat (kg) | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | total body fat (kg) | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Participants were asked: "In general, how satisfied are you with the convenience and simplicity of your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied"). | Atripla Efficacy Analysis Set | Posted | | Number | | Participants | | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Participants were asked: "In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied"). | Atripla Efficacy Analysis Set | Posted | | Number | | Participants | | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Participants were asked: "In general, how satisfied are you with your ability to tolerate your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied"). | Atripla Efficacy Analysis Set | Posted | | Number | | Participants | | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Participants were asked: "In general, how satisfied are you with your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied"). | Atripla Efficacy Analysis Set | Posted | | Number | | Participants | | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. | Participants were asked: "How bothered are you with the side effects of your current treatment regimen?" Possible responses were on a 4-category scale: "does not bother me"; "bothers me a little bit"; "bothers me a lot"; and "bothers me terribly". For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "does not bother me" and "bothers me" ("bothers me" included "bothers me a little bit"; "bothers me a lot"; "bothers me terribly"). | Atripla Efficacy Analysis Set | Posted | | Number | | Participants | | Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| |
| Secondary | Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | Composite Score | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
|---|
| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
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| Secondary | Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). | Atripla Efficacy Analysis Set | Posted | | Mean | Standard Deviation | Composite Score | | Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) | | | | ID | Title | Description |
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| OG000 | All Atripla | Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
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