Phase 3
N=1,857
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00118898 ↗Enrolled (actual)
1,857
Serious AEs
12.9%
Results posted
Jan 2011
Primary outcome: Primary: Time From Randomization to Virologic Failure — 36; 24; 24; 24 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abacavir/Lamivudine (Drug); Atazanavir (Drug); Efavirenz (Drug); Emtricitabine/Tenofovir disoproxil fumarate (Drug); Ritonavir (Drug); Abacavir/Lamivudine placebo (Drug); Emtricitabine/Tenofovir disoproxil fumarate placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Virologic Failure |
36; 24; 24; 24; 96; 36 | — |
| PRIMARY Time From Treatment Dispensation to a Grade 3/4 Safety Event |
2.6; 1.3; 3.0; 1.3; 7.9; 2.0 | — |
| PRIMARY Time From Treatment Dispensation to Treatment Modification |
3.4; 1.4; 7.9; 1.6; 15.0; 2.1 | — |
| SECONDARY Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) |
4; 4; 4; 4; 16; 4 | — |
| SECONDARY The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL |
415; 400; 416; 411; 372; 346 | — |
| SECONDARY Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL |
415; 400; 416; 411; 398; 377 | — |
| SECONDARY Change in CD4 Count (Cells/mm3) From Baseline |
163; 188; 175; 177.5; 220.5; 250.5 | — |
| SECONDARY Number of Participants With Virologic Failure and Emergence of Major Resistance |
27; 41; 5; 12 | — |
| SECONDARY Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. |
6; 11; 6; 8; 14; 25 | — |
| SECONDARY Change in Fasting Total Cholesterol Level From Baseline |
22; 35; 11; 30; 23; 33 | — |
| SECONDARY Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline |
8; 10; 5; 8; 9; 11 | — |
| SECONDARY Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline |
14; 23; 8; 20; 13.5; 18 | — |
| SECONDARY Change in Fasting Triglyceride Level From Baseline |
10; 15; 14; 24; 9; 14 | — |
Summary
Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.
Eligibility Criteria
Inclusion Criteria
- HIV-infected. A resistance assay must be obtained if the participant has evidence of recent infection. More information on this criterion can be found in the protocol.
- Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. Participants who have received ARVs as part of postexposure prophylaxis or who have received an investigational drug that was not an NRTI, NNRTI, or PI are eligible for this study.
- HIV viral load greater than 1, 000 copies/ml within 90 days prior to study entry
- Certain laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the protocol
- Willing to use acceptable forms of contraception
- Parent or guardian able and willing to provide written informed consent, if applicable
- Hepatitis B surface antigen (HBsAg) negative at study entry
Exclusion Criteria
- Immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Individuals receiving either stable physiologic glucocorticoid doses, corticosteroids for acute therapy for pneumocystis pneumonia, or a short course (2 weeks or less) of pharmacologic glucocorticoid therapy will not be excluded.
- Known allergy/sensitivity to study drugs or their formulations
- Active alcohol or drug use that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment or hospitalization. Patients who have completed therapy or are clinically stable on therapy for at least 7 days prior to study entry are not excluded.
- Known clinically relevant cardiac conduction system disease
- Requirement for any current medications that are prohibited with any study treatment.
- Evidence of any major drug resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry.
- Current imprisonment or involuntary incarceration for psychiatric or physical (e.g., infectious disease) illness
- Breastfeeding. Women who become pregnant during the study will be unblinded and required to permanently discontinue their study regimens.
Data sourced from ClinicalTrials.gov (NCT00118898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.