Trial · NCT00811954
Comparative Study of Three NNRTI-Sparing HAART Regimens
NCT00811954, Phase 3, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2014-09-05
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ConductScience Library. Comparative Study of Three NNRTI-Sparing HAART Regimens. Trials, record NCT00811954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00811954
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study of Three NNRTI-Sparing HAART Regimens
- NCT number
- NCT00811954
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,814 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV Infection
- Interventions
- Emtricitabine/tenofovir disoproxil fumarate, Raltegravir, Darunavir, Ritonavir, Atazanavir
- First posted
- 2008-12-19
- Last updated
- 2014-09-05
- Results first posted
- 2014-09-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Probability of First Virologic Failure by Week 96 | From study entry to week 96 | The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry. |
| Primary | Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 | From study entry to week 96 | The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. |
| Secondary | Cumulative Incidence of First Adverse Event by Week 96 | From study entry to week 96 | The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event. The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade \>3 after week 48, and laboratory values grade \>3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up. |
| Secondary | Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96 | From study entry to week 96 | The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96. A composite TLOVR endpoint defined in the CDER of the FDA document "Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval" (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf. If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels \>200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit. |
| Secondary | Presence of Mutations Associated With NRTI Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. |
| Secondary | Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. |
| Secondary | Presence of Mutations Associated With INI Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. |
| Secondary | CD4+ T-cell Count | At Weeks 24, 48, 96, and 144 | The absolute levels of CD4+ T-cell counts (cells/mm3) |
| Secondary | CD4+ T-cell Count Changes From Baseline | Study entry to weeks 24, 48, 96, and 144 | Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count |
| Secondary | Incidence of Death or AIDS Defining Events (CDC Category C) | Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable | The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Probability of First Virologic Failure by Week 96 | From study entry to week 96 | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. | cumulative probability per 100 persons | NUMBER |
| PRIMARY | Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 | From study entry to week 96 | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. | cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Incidence of First Adverse Event by Week 96 | From study entry to week 96 | As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment. | cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96 | From study entry to week 96 | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. | cumulative probability per 100 persons | NUMBER |
| SECONDARY | Presence of Mutations Associated With NRTI Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | Participants who met the criteria for virologic failure with successful sequencing at virologic failure | participants | NUMBER |
| SECONDARY | Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | Participants who met the criteria for virologic failure with successful sequencing at virologic failure | participants | NUMBER |
| SECONDARY | Presence of Mutations Associated With INI Resistance | At the virologic failure at any time throughout the study (up to 213 weeks) | Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure. | participants | NUMBER |
| SECONDARY | CD4+ T-cell Count | At Weeks 24, 48, 96, and 144 | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random. | cells/mm^3 | MEAN |
| SECONDARY | CD4+ T-cell Count Changes From Baseline | Study entry to weeks 24, 48, 96, and 144 | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random. | cells/mm^3 | MEAN |
| SECONDARY | Incidence of Death or AIDS Defining Events (CDC Category C) | Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable | Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. | events per 100 person-years | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Probability of First Virologic Failure by Week 96 | Arm A: ATV/RTV + FTC/TDF | 13 | 95% Confidence Interval 10 to 16 | cumulative probability per 100 persons | |
| Cumulative Probability of First Virologic Failure by Week 96 | Arm B: RAL + FTC/TDF | 10 | 95% Confidence Interval 7 to 12 | cumulative probability per 100 persons | |
| Cumulative Probability of First Virologic Failure by Week 96 | Arm C: DRV/RTV + FTC/TDF | 15 | 95% Confidence Interval 12 to 18 | cumulative probability per 100 persons | |
| Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 | Arm A: ATV/RTV + FTC/TDF | 14 | 95% Confidence Interval 12 to 17 | cumulative events per 100 persons | |
| Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 | Arm B: RAL + FTC/TDF | 1 | 95% Confidence Interval 1 to 3 | cumulative events per 100 persons | |
| Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 | Arm C: DRV/RTV + FTC/TDF | 5 | 95% Confidence Interval 3 to 7 | cumulative events per 100 persons | |
| Cumulative Incidence of First Adverse Event by Week 96 | Arm A: ATV/RTV + FTC/TDF | 81 | 95% Confidence Interval 77 to 84 | cumulative events per 100 persons | |
| Cumulative Incidence of First Adverse Event by Week 96 | Arm B: RAL + FTC/TDF | 59 | 95% Confidence Interval 55 to 63 | cumulative events per 100 persons | |
| Cumulative Incidence of First Adverse Event by Week 96 | Arm C: DRV/RTV + FTC/TDF | 65 | 95% Confidence Interval 61 to 69 | cumulative events per 100 persons | |
| Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96 | Arm A: ATV/RTV + FTC/TDF | 31 | 95% Confidence Interval 27 to 35 | cumulative probability per 100 persons |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: ATV/RTV + FTC/TDF | 605 | |
| Overall Study | STARTED | Arm B: RAL + FTC/TDF | 603 | |
| Overall Study | STARTED | Arm C: DRV/RTV + FTC/TDF | 601 | |
| Overall Study | COMPLETED | Arm A: ATV/RTV + FTC/TDF | 516 | |
| Overall Study | COMPLETED | Arm B: RAL + FTC/TDF | 531 | |
| Overall Study | COMPLETED | Arm C: DRV/RTV + FTC/TDF | 500 | |
| Overall Study | NOT COMPLETED | Arm A: ATV/RTV + FTC/TDF | 89 | |
| Overall Study | NOT COMPLETED | Arm B: RAL + FTC/TDF | 72 | |
| Overall Study | NOT COMPLETED | Arm C: DRV/RTV + FTC/TDF | 101 |
Source ClinicalTrials.gov
Adverse events912
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 | Arm A: ATV/RTV + FTC/TDF | 40 | 605 | |
| other | Ocular icterus | Eye disorders | Arm B: RAL + FTC/TDF | 1 | 603 | |
| other | Ocular icterus | Eye disorders | Arm C: DRV/RTV + FTC/TDF | 0 | 601 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: ATV/RTV + FTC/TDF | 35 | 605 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: RAL + FTC/TDF | 23 | 603 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm C: DRV/RTV + FTC/TDF | 32 | 601 | |
| other | Anogenital dysplasia | Gastrointestinal disorders | Arm A: ATV/RTV + FTC/TDF | 31 | 605 | |
| other | Anogenital dysplasia | Gastrointestinal disorders | Arm B: RAL + FTC/TDF | 25 | 603 | |
| other | Anogenital dysplasia | Gastrointestinal disorders | Arm C: DRV/RTV + FTC/TDF | 23 | 601 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm A: ATV/RTV + FTC/TDF | 61 | 605 |
1 to 10 of 912Source ClinicalTrials.gov
See all 912 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: ATV/RTV + FTC/TDF | ||
| Total, all-cause mortality | Arm B: RAL + FTC/TDF | ||
| Total, all-cause mortality | Arm C: DRV/RTV + FTC/TDF | ||
| Total, other adverse events | Arm A: ATV/RTV + FTC/TDF | 565 | 605 |
| Total, other adverse events | Arm B: RAL + FTC/TDF | 516 | 603 |
| Total, other adverse events | Arm C: DRV/RTV + FTC/TDF | 532 | 601 |
| Total, serious adverse events | Arm A: ATV/RTV + FTC/TDF | 139 | 605 |
| Total, serious adverse events | Arm B: RAL + FTC/TDF | 126 | 603 |
| Total, serious adverse events | Arm C: DRV/RTV + FTC/TDF | 125 | 601 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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