Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Atazanavir Sulfate; Dideoxynucleosides; Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Ritonavir; Tenofovir

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.