Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Atazanavir + 2 NRTIs; Atazanavir + Ritonavir + 2 NRTIs
Intervention description: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs); Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Naive; HIV-1 infected treatment naive patients

Summary:

      The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load
      < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an
      initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART
      regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous
      NRTI backbone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).

          -  Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.

          -  Subjects who have a CD4 count ≥ 50 cells/mm3.

          -  Men and women, ages 18 years of age or older (or minimum age as determined by local
             regulatory or as legal requirements dictate).

          -  Both females of child-bearing potential and males must utilize effective barrier
             contraception. Other contraception in addition to barrier methods is permitted; refer
             to the Investigator Brochure for details regarding potential interactions with ATV and
             some oral contraceptives

        Exclusion Criteria:

          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
             the entire study period and for up to 8 weeks after the study.

          -  WOCBP using a prohibited contraceptive method. Caution is warranted with
             coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see
             Investigator Brochure for details

          -  Women who are pregnant or breastfeeding

          -  Women with a positive pregnancy test on enrollment or prior to study drug
             administration.

          -  Presence of a newly diagnosed HIV-related opportunistic infection or any medical
             condition requiring acute therapy at the time of enrollment

          -  Primary HIV infection

          -  Medical History and Concurrent Diseases

          -  Active alcohol or substance use sufficient, in the investigator's opinion, to prevent
             adequate compliance with study therapy or to increase the risk of developing
             pancreatitis or chemical hepatitis Physical and Laboratory Test Findings

          -  Screening laboratory values measured as follows:

          -  Grade IV glucose,

          -  Grade IV electrolytes,

          -  Grade IV transaminases,

          -  Grade IV hematology.

          -  Hypersensitivity to any component of the formulation of study drug

          -  Prior history of taking any ARV for more than 10 days

          -  Concomitant administration of tenofovir (TDF).

          -  Refer to Section 6.4.1 which details all prohibited therapies