Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Abacavir/Lamivudine; Atazanavir; Efavirenz; Emtricitabine/Tenofovir disoproxil fumarate; Ritonavir; Abacavir/Lamivudine placebo; Emtricitabine/Tenofovir disoproxil fumarate placebo
Intervention description: 600 mg abacavir/300 mg lamivudine tablet taken orally daily; 300 mg tablet taken orally daily; 600 mg tablet taken orally daily; 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily; 100 mg tablet taken orally daily; Placebo tablet taken orally daily; Placebo tablet taken orally daily
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Lamivudine; Emtricitabine; Abacavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Efavirenz; Dideoxynucleosides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1864.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment Naive

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.