Trial · NCT00035932
Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
NCT00035932, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2010-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV. Trials, record NCT00035932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00035932
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
- NCT number
- NCT00035932
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 571 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- HIV Infections
- Interventions
- Atazanavir + ritonavir + tenofovir + nucleoside, Atazanavir + saquinavir + tenofovir + nucleoside, Lopinavir/ritonavir + tenofovir + nucleoside
- First posted
- 2002-05-08
- Last updated
- 2010-12-24
- Results first posted
- 2010-12-24
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | Baseline, Week 24 | |
| Primary | Mean Change From Baseline in HIV RNA at Week 48 | Baseline, Week 48 | |
| Primary | Mean Change From Baseline in HIV RNA at Week 96 | Baseline, Week 96 | |
| Secondary | Mean Change From Baseline in HIV RNA at Week 2 | Baseline, Week 2 | |
| Secondary | Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | Baseline, Week 24 | 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. |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) | Baseline, Week 48 | 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. |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 | Baseline, 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. |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24 | Week 24 | |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity | Baseline, Week 24 | 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. |
| Secondary | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48 | Week 48 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | Baseline, Week 24 | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | log10 c/mL | MEAN |
| SECONDARY | Mean Change From Baseline in HIV RNA at Week 2 | Baseline, Week 2 | Treated participants, as-randomized (refers to the treatment regimen assigned at randomization). | log10 c/mL | MEAN |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | Baseline, Week 24 | 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. | participants | NUMBER |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) | Baseline, Week 48 | 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. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline in HIV RNA at Week 48 | Baseline, Week 48 | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | log10 c/mL | MEAN |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 | Baseline, Week 96 | Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement. | participants | NUMBER |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24 | Week 24 | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | participants | NUMBER |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity | Baseline, Week 24 | 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. | participants | NUMBER |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48 | Week 48 | Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization). | Participants | NUMBER |
| SECONDARY | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity | Baseline, Week 48 | 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. | participants | NUMBER |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | ATV 300 mg / RTV | -1.86 | Standard Error 0.11 | log10 c/mL | |
| Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | ATV 400 mg / SQV | -1.52 | Standard Error 0.13 | log10 c/mL | |
| Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 | LPV / RTV | -1.89 | Standard Error 0.11 | log10 c/mL | |
| Mean Change From Baseline in HIV RNA at Week 2 | ATV 300 mg / RTV | -1.18 | Standard Error 0.06 | log10 c/mL | |
| Mean Change From Baseline in HIV RNA at Week 2 | ATV 400 mg / SQV | -1.14 | Standard Error 0.07 | log10 c/mL | |
| Mean Change From Baseline in HIV RNA at Week 2 | LPV / RTV | -1.30 | Standard Error 0.06 | log10 c/mL | |
| Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | ATV 300 mg / RTV | Overall (n=120, 115, 123) | 95 | participants | |
| Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | ATV 400 mg / SQV | Overall (n=120, 115, 123) | 74 | participants | |
| Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | LPV / RTV | Overall (n=120, 115, 123) | 93 | participants | |
| Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) | ATV 300 mg / RTV | PI Sensitive (n=88, 83, 88) | 79 | participants |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ATV 300 mg / RTV | 119 | |
| Overall Study | STARTED | ATV 400 mg / SQV | 110 | |
| Overall Study | STARTED | LPV / RTV | 118 | |
| Overall Study | Discontinued Prior to Week 48 Visit | ATV 300 mg / RTV | 26 | |
| Overall Study | Discontinued Prior to Week 48 Visit | ATV 400 mg / SQV | 29 | |
| Overall Study | Discontinued Prior to Week 48 Visit | LPV / RTV | 13 | |
| Overall Study | Discontinued Between Weeks 48 and 96 | ATV 300 mg / RTV | 26 | |
| Overall Study | Discontinued Between Weeks 48 and 96 | ATV 400 mg / SQV | 27 | |
| Overall Study | Discontinued Between Weeks 48 and 96 | LPV / RTV | 30 | |
| Overall Study | Discontinued on or After Week 96 | ATV 300 mg / RTV | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events438
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | OCULAR ICTERUS | Eye disorders | ATV300/RTV | 13 | 119 | |
| other | OCULAR ICTERUS | Eye disorders | ATV400/SQV | 4 | 110 | |
| other | OCULAR ICTERUS | Eye disorders | LPV/RTV | 0 | 118 | |
| other | LIPASE INCREASED | Investigations | ATV300/RTV | 8 | 119 | |
| other | LIPASE INCREASED | Investigations | ATV400/SQV | 2 | 110 | |
| other | LIPASE INCREASED | Investigations | LPV/RTV | 8 | 118 | |
| other | WEIGHT DECREASED | Investigations | ATV300/RTV | 10 | 119 | |
| other | WEIGHT DECREASED | Investigations | ATV400/SQV | 9 | 110 | |
| other | WEIGHT DECREASED | Investigations | LPV/RTV | 13 | 118 | |
| other | BLOOD BILIRUBIN INCREASED | Investigations | ATV300/RTV | 11 | 119 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATV300/RTV | ||
| Total, all-cause mortality | ATV400/SQV | ||
| Total, all-cause mortality | LPV/RTV | ||
| Total, other adverse events | ATV300/RTV | 101 | 119 |
| Total, other adverse events | ATV400/SQV | 95 | 110 |
| Total, other adverse events | LPV/RTV | 104 | 118 |
| Total, serious adverse events | ATV300/RTV | 22 | 119 |
| Total, serious adverse events | ATV400/SQV | 22 | 110 |
| Total, serious adverse events | LPV/RTV | 19 | 118 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ATV 300 mg / RTV vs LPV / RTV: Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96 | Trial comparisons |
| ATV 300 mg / RTV vs LPV / RTV: Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96 | Trial comparisons |
| ATV 300 mg / RTV vs LPV / RTV: Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96 | Trial comparisons |
| ATV 300 mg / RTV vs LPV / RTV: Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00035932
GET https://conductscience.org/api/trials/v1/NCT00035932/registered?page=2