Comparative Study of Three NNRTI-Sparing HAART Regimens
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Emtricitabine/tenofovir disoproxil fumarate; Raltegravir; Darunavir; Ritonavir; Atazanavir
Intervention description: 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).; 400 mg taken orally twice daily. An integrase inhibitor (INI).; 800 mg taken orally once daily. A protease inhibitor (PI).; 100 mg taken orally once daily. A protease inhibitor (PI).; 300 mg taken orally once daily. A protease inhibitor (PI).
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Darunavir; Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1814.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment naive; Treatment inexperienced

Summary:

      The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected
      patients who have never received anti-HIV therapy be treated with a triple drug regimen. The
      most commonly prescribed and successful regimen contains the medication efavirenz (EFV).
      However, this regimen may not be an option for everyone, hence alternative regimens are
      needed.

      This study was designed to look at how well different combinations of anti-HIV drugs work to
      decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in
      people who have never received anti-HIV therapy. This study also examined drug tolerability
      and safety for the various drug combinations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected

          -  No evidence of any exclusionary mutations defined as any major NRTI or PI
             resistance-associated mutation on any genotype or evidence of significant NRTI or PI
             resistance on any phenotype performed at any time prior to study entry.
             NNRTI-associated resistance mutations are not excluded. More information on this
             criterion can be found in the study protocol.

          -  No prior anti-HIV therapy. More information on this criterion can be found in the
             study protocol.

          -  Viral load is 1000 copies/mL or higher, as measured within 90 days prior to study
             entry

          -  Certain laboratory values obtained within 60 days prior to study entry

          -  Ability to obtain RTV by prescription

          -  Completed cardiovascular risk assessment. More information on this criterion can be
             found in the study protocol.

          -  Must agree to use acceptable forms of contraception while receiving study drugs and
             for 6 weeks after stopping the medications. More information on this criterion is
             available in the protocol.

          -  Negative pregnancy test within 72 hours before initiating antiretroviral medication

          -  Participating in research at any AIDS Clinical Trial Group (ACTG) clinical research
             site or select International Maternal Pediatric Adolescent AIDS Clinical Trials
             (IMPAACT) group sites

          -  Ability and willingness of subject or legal guardian/representative to give written
             informed consent

        Exclusion Criteria:

          -  Use of immunomodulators, HIV vaccine, systemic cytotoxic chemotherapy, or
             investigational therapy within 30 days prior to study entry. Those using stable
             physiologic glucocorticoid doses, a short course of pharmacologic glucocorticoid,
             corticosteroids for acute therapy treating an opportunistic infection, inhaled or
             topical corticosteroids, or granulocyte-colony stimulating factor (G-CSF) or
             granulocyte-macrophage colony-stimulating factor (GM-CSF) will not be excluded.

          -  Known allergy or sensitivity to study drugs or their ingredients. A history of sulfa
             allergy is not excluded.

          -  Any condition that, in the opinion of the investigator, would compromise the
             participant's ability to participate in the study

          -  Serious illness requiring systemic treatment and/or hospitalization until participant
             either completes therapy or is clinically stable on therapy, in the opinion of the
             investigator, for at least 7 days prior to study entry

          -  Requirement for any current medications that are prohibited with any study drugs

          -  Current imprisonment or involuntary incarceration in a medical facility for
             psychiatric or physical illness

          -  Any prior use of entecavir for treatment of hepatitis B for greater than 8 weeks while
             the participant was known to be HIV infected

          -  Presence of decompensated cirrhosis

          -  Pregnant or breastfeeding