Trial · NCT00272779
BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
NCT00272779, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2011-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada. Trials, record NCT00272779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00272779
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
- NCT number
- NCT00272779
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,057 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- HIV Infections
- Interventions
- ATV, RTV, Tenofovi-Emtricitabine (TDF/FTC) tablet, LPV
- First posted
- 2006-01-09
- Last updated
- 2011-05-09
- Results first posted
- 2011-05-09
Source ClinicalTrials.gov
Registered outcomes88
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 | Baseline (Day 1) and Week 48 | HIV RNA \< 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment. |
| Primary | Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD. | Cmax was derived from plasma concentration versus time data. |
| Primary | Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4. |
| Primary | Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | Cmin was derived from the plasma concentration versus time data. |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | Tmax was derived from the plasma concentration versus time data. |
| Primary | Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | T-half was derived from the plasma concentration versus time data. |
| Primary | Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively). |
| Primary | Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates. |
| Primary | Cmax of RTV at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | Cmax was derived from plasma concentration versus time data. |
| Primary | AUC (0-24) of RTV at Week 4 | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. | AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK. |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 registered outcomesOutcomes88
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 | Baseline (Day 1) and Week 48 | Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers. | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV RNA < 400 c/mL at Week 48 | Baseline (Day 1) and Week 48 | Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers. | Participants | NUMBER |
| SECONDARY | Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) | Baseline (Day 1) and Week 48 | Efficacy analyses of the treatment period are based on randomized population. | Participants | NUMBER |
| SECONDARY | Reduction of log10 HIV RNA Levels From Baseline to Week 48 | Baseline (Day 1) and Week 48 | All treated participants with data for this parameter. | c/mL | MEAN |
| SECONDARY | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 | Baseline (Day 1) and Week 48. | All treated participants with data for this parameter. | c/mm^3 | MEAN |
| SECONDARY | Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 | Baseline (Day 1) and Week 48 | Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 | From baseline (Day 1) to Week 48. | Safety analyses of the treatment period are based on treated population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC) | At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. | Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 | At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. | Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 | At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. | Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Participants | NUMBER |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 outcomesResults by group524
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 343 | Participants | ||
| Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 338 | Participants | ||
| Number of Participants With HIV RNA < 400 c/mL at Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 377 | Participants | ||
| Number of Participants With HIV RNA < 400 c/mL at Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 365 | Participants | ||
| Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 377 | Participants | ||
| Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 363 | Participants | ||
| Reduction of log10 HIV RNA Levels From Baseline to Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -3.09 | Standard Error 0.042 | c/mL | |
| Reduction of log10 HIV RNA Levels From Baseline to Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -3.13 | Standard Error 0.037 | c/mL | |
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 203 | Standard Error 7.1 | c/mm^3 | |
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 219 | Standard Error 7.2 | c/mm^3 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Through Week 48 | STARTED | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 440 | |
| Baseline Through Week 48 | STARTED | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 443 | |
| Baseline Through Week 48 | RECEIVED ANY TREATMENT | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 441 | |
| Baseline Through Week 48 | RECEIVED ANY TREATMENT | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 437 | |
| Baseline Through Week 48 | TREATED AS RANDOMIZED | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 438 | |
| Baseline Through Week 48 | TREATED AS RANDOMIZED | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 440 | |
| Baseline Through Week 48 | Discontinued Before Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 39 | |
| Baseline Through Week 48 | Discontinued Before Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 58 | |
| Baseline Through Week 48 | Discontinued on or After Week 48 | ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 14 | |
| Baseline Through Week 48 | Discontinued on or After Week 48 | LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 14 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events282
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 | ATV/RTV/Tenofovir/Emtricitabine | 43 | 441 | |
| other | OCULAR ICTERUS | Eye disorders | LPV/RTV/Tenofovir/Emtricitabine | 0 | 437 | |
| other | JAUNDICE | Hepatobiliary disorders | ATV/RTV/Tenofovir/Emtricitabine | 83 | 441 | |
| other | JAUNDICE | Hepatobiliary disorders | LPV/RTV/Tenofovir/Emtricitabine | 2 | 437 | |
| other | HYPERBILIRUBINAEMIA | Hepatobiliary disorders | ATV/RTV/Tenofovir/Emtricitabine | 51 | 441 | |
| other | HYPERBILIRUBINAEMIA | Hepatobiliary disorders | LPV/RTV/Tenofovir/Emtricitabine | 3 | 437 | |
| other | HEADACHE | Nervous system disorders | ATV/RTV/Tenofovir/Emtricitabine | 81 | 441 | |
| other | HEADACHE | Nervous system disorders | LPV/RTV/Tenofovir/Emtricitabine | 67 | 437 | |
| other | DIZZINESS | Nervous system disorders | ATV/RTV/Tenofovir/Emtricitabine | 34 | 441 | |
| other | DIZZINESS | Nervous system disorders | LPV/RTV/Tenofovir/Emtricitabine | 29 | 437 |
1 to 10 of 282Source ClinicalTrials.gov
See all 282 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ATV/RTV/Tenofovir/Emtricitabine | ||
| Total, all-cause mortality | LPV/RTV/Tenofovir/Emtricitabine | ||
| Total, other adverse events | ATV/RTV/Tenofovir/Emtricitabine | 355 | 441 |
| Total, other adverse events | LPV/RTV/Tenofovir/Emtricitabine | 370 | 437 |
| Total, serious adverse events | ATV/RTV/Tenofovir/Emtricitabine | 61 | 441 |
| Total, serious adverse events | LPV/RTV/Tenofovir/Emtricitabine | 48 | 437 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants With HIV RNA < 50 c/mL) at Week 96 | Trial comparisons |
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48 | Trial comparisons |
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) | Trial comparisons |
| ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants With HIV RNA < 400 c/mL) at Week 96 | Trial comparisons |
| ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants With HIV RNA < 400 c/mL at Week 48 | Trial comparisons |
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD vs LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD: Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 | Trial comparisons |
| ATV/RTV/Tenofovir/Emtricitabine vs LPV/RTV/Tenofovir/Emtricitabine: serious adverse events | 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/NCT00272779
GET https://conductscience.org/api/trials/v1/NCT00272779/registered?page=2