| Primary | Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.86± 0.11
- OG001-1.52± 0.13
- OG002-1.89± 0.11
|
|
| | 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 |
|---|
| | | | | | Time-Averaged Difference | 0.14 | | | 2-Sided | 97.5 | -0.09 | 0.37 | | | | Yes | Non-Inferiority or Equivalence | The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10. | |
|
| Secondary | Mean Change From Baseline in HIV RNA at Week 2 | | Treated participants, as-randomized (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 2 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI. | Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants. | Posted | | Number | | participants | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) | Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI. | Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants. | Posted | | Number | | participants | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Primary | Mean Change From Baseline in HIV RNA at Week 48 | | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 | Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96. | Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement. | Posted | | Number | | participants | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24 | | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity | Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI. | As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity. | Posted | | Number | | participants | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48 | | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity | Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI. | As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity. | Posted | | Number | | participants | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96 | | Randomized participants while on initial regimen (completers censored). | Posted | | Number | | Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24 | Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participants while on initial regimen Randomized participants, (completers censored). | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48 | Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Secondary | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96 | Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participants while on initial regimen (completers censored). | Posted | | Number | | participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24 | Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
|
| Secondary | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48 | Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participantsRandomized participants while on initial regimen (completers censored). | Posted | | Number | | participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96 | Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. | Randomized participants while on initial regimen (completers censored) | Posted | | Number | | participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Change From Baseline in CD4 Cell Count at Week 24 | | Randomized participantsRandomized participants while on initial regimen (completers censored). | Posted | | Mean | Standard Error | cells/mm3 | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | | Randomized participants while on initial regimen (completers censored). | Posted | | Mean | Standard Error | cells/mm3 | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Change From Baseline in CD4 Cell Count at Week 96 | | Randomized participants (while on initial regimen) with evaluation at time point | Posted | | Mean | Standard Error | cells/mm3 | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 | Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored. | Week 24: Participants with evaluable PK measurements | Posted | | Number | | Pearson Correlation Coefficient | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19]) | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3]) |
| |
| Secondary | Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48 | Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored. | Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants. | Posted | | Number | | Pearson Correlation Coefficient | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19]) | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3]) |
| |
| Secondary | Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 | Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored. | Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | Pearson Correlation Coefficient | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21]) | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20]) |
| |
| Secondary | Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48 | Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored. | Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants. | Posted | | Number | | Pearson Correlation Coefficient | | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21]) | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20]) |
| |
| Secondary | Lipid Mean Percent Change From Baseline at Week 24 | Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. | Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Lipid Mean Percent Change From Baseline at Week 48 | Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. | Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | percent change in lipid values | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
| |
| Secondary | Lipid Mean Percent Change From Baseline at Week 96, Observed Values | Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. | Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | percent change in lipid values | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 | AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. | Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below. | Posted | | Number | | participants | | From Enrollment through Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 |
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| Secondary | Most Common AEs and AEs of Interest Through Week 48 | Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia. | Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | participants | | From Enrollment to Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Fasting Glucose Mean Change From Baseline at Week 24 | | Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | mg/dL | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Fasting Glucose Mean Change From Baseline at Week 48 | | Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | mg/dL | | Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Grade 3/4 Laboratory Abnormalities Through Week 48 | Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4). | Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Number | | participants | | From Enrollment to Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | |
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| Secondary | Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula. | Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint | Posted | | Mean | Standard Error | msec | | Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | PR Interval and Change From Baseline by Analysis Time Point | The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function. | Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint | Posted | | Mean | Standard Error | msec | | Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire | The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance. | Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.) | Posted | | Number | | participants | | Baseline, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | |
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| Secondary | Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) | The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03. | Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | |
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| Secondary | Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) | The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS. | Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 |
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| Primary | Mean Change From Baseline in HIV RNA at Week 96 | | Randomized participants while on initial regimen | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Number of Participants Utilizing Resources for Managing Lipid Elevation | Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions. | Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done. | Posted | | Number | | Participants | | Baseline, Week 24, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG002 | LPV / RTV | LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values | The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose. | Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | ng/mL | | collected at the pre-dose time point after receiving atazanavir for at least four weeks | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | HIV IC50 at Week 24 | IC50: inhibitory concentration of drug required to reduce viral replication by 50%. | Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | ng/mL | | Week 24 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Inhibitory Quotient at Week 24 | Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50. | Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | ratio | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | Inhibitory Quotient at Week 48 | Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50. | Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants. | Posted | | Mean | Standard Error | ratio | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 | Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins. | Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization). | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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| Secondary | HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48 | Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins. | Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants. | Posted | | Mean | Standard Error | log10 c/mL | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV 300 mg / RTV | ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study | | OG001 | ATV 400 mg / SQV | ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study |
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