Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Atazanavir; Didanosine (enteric-coated); Efavirenz; Emtricitabine; Emtricitabine/Tenofovir disoproxil fumarate; Lamivudine/Zidovudine
Intervention description: 400 mg taken orally daily; 400 mg taken orally daily; 600 mg taken orally daily; 200 mg taken orally daily; 200 mg/300 mg taken orally once daily; 150 mg/300 mg taken orally twice daily
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Efavirenz; Atazanavir Sulfate; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Didanosine; Lamivudine, zidovudine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1571.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Naive; Adherence; Drug Resistance; Treatment Failure

Summary:

      This study compared 3 different three-drug combinations in HIV infected individuals starting
      their first HIV treatment regimens. Participants were recruited from resource-limited areas
      in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis
      was each of the once daily combinations (PI based, or NNRTI based) would not have inferior
      efficacy compared to the twice daily NNRTI based combination.
    

Eligibility criteria:

        Inclusion Criteria :>

          -  HIV-1 infected>

          -  CD4 count fewer than 300 cells/mm3 >

          -  Viral load test result>

          -  Absolute Neutrophil Count at least 750mm3 >

          -  Hemoglobin at least 7.5 g/dL>

          -  Platelet count at least 50,000/mm3>

          -  Calculated creatinine clearance at least 60 mL/min>

          -  A , A, and alkaline phosphatase <= 5 times upper limit of normal>

          -  total bilirubin <= 2.5 times upper limit of normal>

          -  Karnofsky performance score of 70 or higher>

          -  Plans to stay in the area for the duration of the study>

          -  Agrees to use acceptable forms of contraception for the duration of the study>

        Exclusion Criteria:>

          -  More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period
             for the purpose of pMTCT)>

          -  Acute therapy for serious medical illnesses within 14 days prior to study entry>

          -  Certain abnormal laboratory values>

          -  Radiation therapy or chemotherapy within 45 days prior to study entry. >

          -  Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days
             prior to study entry. >

          -  Current alcohol or drug abuse that, in the opinion of the site investigator, would
             interfere with study participation>

          -  Inflamed pancreas within 3 years prior to study entry>

          -  Allergy/sensitivity to any of the study drugs or their formulations>

          -  Heart rate less than 40 beats/min>

          -  History of untreated, active second- or third-degree heart block>

          -  Currently detained in jail or for treatment of a psychiatric or physical illness>

          -  Vomiting or inability to swallow medications>

          -  Pregnancy>