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

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00118898

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

1864

Starts

2005-09-01

Expected to finish

2009-11-01

Last updated by the study team

2018-10-12

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Center CRS (601) — Los Angeles, California, United States
• Stanford CRS (501) — Palo Alto, California, United States
• Ucsd, Avrc Crs (701) — San Diego, California, United States
• Ucsf Aids Crs (801) — San Francisco, California, United States
• San Mateo County AIDS Program (505) — Stanford, California, United States
• Willow Clinic (507) — Stanford, California, United States
• Harbor-UCLA Med. Ctr. CRS (603) — Torrance, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• Georgetown University CRS (GU CRS) (1008) — Washington D.C., District of Columbia, United States
• University of Miami AIDS CRS (901) — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• The Ponce de Leon Center CRS (5802) — Atlanta, Georgia, United States
• Northwestern University CRS (2701) — Chicago, Illinois, United States
• Cook County Hospital Core Center (2705) — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago, Illinois, United States
• Indiana University Hospital (2601) — Indianapolis, Indiana, United States
• Wishard Hospital (2603) — Indianapolis, Indiana, United States
• Univ of Iowa Hosp and Clinic (1504) — Iowa City, Iowa, United States
• IHV Baltimore Treatment CRS (4651) — Baltimore, Maryland, United States
• Johns Hopkins Adult AIDS CRS (201) — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS (101) — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States
• Bmc Actg Crs (104) — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS (103) — Boston, Massachusetts, United States
• Usc Crs (1201) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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