Trial · NCT00118898
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
NCT00118898, Phase 3, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2011-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults. Trials, record NCT00118898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
- NCT number
- NCT00118898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,864 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV Infections
- Interventions
- Abacavir/Lamivudine, Atazanavir, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Ritonavir, Abacavir/Lamivudine placebo, Emtricitabine/Tenofovir disoproxil fumarate placebo
- First posted
- 2005-07-12
- Last updated
- 2018-10-12
- Results first posted
- 2011-01-10
- Limitations and caveats
HIV-1 drug resistance testing and HLA-B\*5701 testing were not standard of care during enrollment. EFV and RTV-boosted ATV were open-label, and blinded FTC/TDF vs. ABC/3TC were unblinded in the \>=100,000 cp/mL screening viral load stratum Feb 2008.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to Virologic Failure | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or \>=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. |
| Primary | Time From Treatment Dispensation to a Grade 3/4 Safety Event | All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks. | Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. |
| Primary | Time From Treatment Dispensation to Treatment Modification | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. |
| Secondary | Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. |
| Secondary | The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL | At Weeks 48 and 96 | |
| Secondary | Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL | At Weeks 48 and 96 | |
| Secondary | Change in CD4 Count (Cells/mm3) From Baseline | At Weeks 48 and 96 | Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). |
| Secondary | Number of Participants With Virologic Failure and Emergence of Major Resistance | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. |
| Secondary | Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm |
| Secondary | Change in Fasting Total Cholesterol Level From Baseline | At Weeks 48 and 96 | Only fasting results are included. The protocol did not require that samples be collected fasting. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to Virologic Failure | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Weeks | NUMBER |
| OTHER_PRE_SPECIFIED | Amount of Study Follow-up | Follow-up time was variable, median follow-up was 138 weeks | Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen. | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Virologic Failure | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | participants | NUMBER |
| SECONDARY | Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Weeks | NUMBER |
| SECONDARY | The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL | At Weeks 48 and 96 | Intention to treat: All participants with RNA data were included, complete-case approach. | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL | At Weeks 48 and 96 | Intention to treat: All participants with RNA data were included, complete-case approach. | Participants | NUMBER |
| SECONDARY | Change in CD4 Count (Cells/mm3) From Baseline | At Weeks 48 and 96 | Intention to treat: All participants with CD4 data were included, complete-case approach. | Cells/mm3 | MEDIAN |
| SECONDARY | Number of Participants With Virologic Failure and Emergence of Major Resistance | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen. | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Participants | NUMBER |
| SECONDARY | Change in Fasting Total Cholesterol Level From Baseline | At Weeks 48 and 96 | Intention to treat: All participants with fasting lipids data were included, complete-case approach. | mg/dL | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomization to Virologic Failure | EFV, FTC/TDF, and Placebo ABC/3TC | 5th percentile time to virologic failure | 36 | 95% Confidence Interval 24 to 60 | Weeks |
| Time From Randomization to Virologic Failure | EFV, Placebo FTC/TDF, and ABC/3TC | 5th percentile time to virologic failure | 24 | 95% Confidence Interval 16 to 24 | Weeks |
| Time From Randomization to Virologic Failure | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 5th percentile time to virologic failure | 24 | 95% Confidence Interval 24 to 48 | Weeks |
| Time From Randomization to Virologic Failure | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 5th percentile time to virologic failure | 24 | 95% Confidence Interval 16 to 24 | Weeks |
| Time From Randomization to Virologic Failure | EFV, FTC/TDF, and Placebo ABC/3TC | 10th percentile time to virologic failure | 96 | 95% Confidence Interval 72 to 132 | Weeks |
| Time From Randomization to Virologic Failure | EFV, Placebo FTC/TDF, and ABC/3TC | 10th percentile time to virologic failure | 36 | 95% Confidence Interval 24 to 60 | Weeks |
| Time From Randomization to Virologic Failure | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 10th percentile time to virologic failure | 84 | 95% Confidence Interval 48 to 156 | Weeks |
| Time From Randomization to Virologic Failure | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 10th percentile time to virologic failure | 36 | 95% Confidence Interval 24 to 60 | Weeks |
| Amount of Study Follow-up | EFV, FTC/TDF, and Placebo ABC/3TC | 141.4 | Inter-Quartile Range 108 to 169 | Weeks | |
| Amount of Study Follow-up | EFV, Placebo FTC/TDF, and ABC/3TC | 133.3 | Inter-Quartile Range 101.3 to 168.0 | Weeks |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EFV, FTC/TDF, and Placebo ABC/3TC | 464 | |
| Overall Study | STARTED | EFV, Placebo FTC/TDF, and ABC/3TC | 465 | |
| Overall Study | STARTED | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 465 | |
| Overall Study | STARTED | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 463 | |
| Overall Study | Initiated Treatment | EFV, FTC/TDF, and Placebo ABC/3TC | 461 | |
| Overall Study | Initiated Treatment | EFV, Placebo FTC/TDF, and ABC/3TC | 461 | |
| Overall Study | Initiated Treatment | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 464 | |
| Overall Study | Initiated Treatment | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 462 | |
| Overall Study | COMPLETED | EFV, FTC/TDF, and Placebo ABC/3TC | 343 | |
| Overall Study | COMPLETED | EFV, Placebo FTC/TDF, and ABC/3TC | 324 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events560
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 | Abnormal dreams | Psychiatric disorders | EFV, FTC/TDF, and Placebo ABC/3TC | 20 | 461 | |
| other | Abnormal dreams | Psychiatric disorders | EFV, Placebo FTC/TDF, and ABC/3TC | 26 | 461 | |
| other | Abnormal dreams | Psychiatric disorders | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 2 | 464 | |
| other | Abnormal dreams | Psychiatric disorders | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 3 | 462 | |
| other | Alanine aminotransferase increased | Investigations | EFV, FTC/TDF, and Placebo ABC/3TC | 67 | 461 | |
| other | Alanine aminotransferase increased | Investigations | EFV, Placebo FTC/TDF, and ABC/3TC | 70 | 461 | |
| other | Alanine aminotransferase increased | Investigations | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 53 | 464 | |
| other | Alanine aminotransferase increased | Investigations | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 52 | 462 | |
| other | Aspartate aminotransferase increased | Investigations | EFV, FTC/TDF, and Placebo ABC/3TC | 73 | 461 | |
| other | Aspartate aminotransferase increased | Investigations | EFV, Placebo FTC/TDF, and ABC/3TC | 67 | 461 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EFV, FTC/TDF, and Placebo ABC/3TC | ||
| Total, all-cause mortality | EFV, Placebo FTC/TDF, and ABC/3TC | ||
| Total, all-cause mortality | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | ||
| Total, all-cause mortality | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | ||
| Total, other adverse events | EFV, FTC/TDF, and Placebo ABC/3TC | 434 | 461 |
| Total, other adverse events | EFV, Placebo FTC/TDF, and ABC/3TC | 433 | 461 |
| Total, other adverse events | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 453 | 464 |
| Total, other adverse events | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 461 | 462 |
| Total, serious adverse events | EFV, FTC/TDF, and Placebo ABC/3TC | 48 | 461 |
| Total, serious adverse events | EFV, Placebo FTC/TDF, and ABC/3TC | 62 | 461 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers20
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00118898
GET https://conductscience.org/api/trials/v1/NCT00118898/registered?page=2