NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Emtricitabine; Emtricitabine/Tenofovir disoproxil fumarate; Lopinavir/Ritonavir; Nevirapine; Tenofovir disoproxil fumarate
Intervention description: 200 mg taken orally; 200/300 mg taken orally; 400/100 mg taken orally; 200 mg taken orally; 300 mg taken orally
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Nevirapine; 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: 745.0
Sex: Female
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Treatment Experienced; Treatment Naive; MTCT; HIV Seronegativity

Summary:

      Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV
      drug regimens. However, HIV infected women who have previously taken the single dose NNRTI
      nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not
      respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs,
      protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs.
      This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have
      taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an
      NNRTI with regimens including a PI in women who have never taken NVP.
    

Eligibility criteria:

        Inclusion Criteria for All Participants:

          -  HIV infected

          -  CD4 count less than 200 cells/mm^3 within 90 days prior to study entry

          -  Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days
             prior to study entry

          -  the following laboratory values obtained within 45 days prior to study entry: absolute
             neutrophil count>=750/mm^3;Hemoglobin>=7.0g/dL;platelet count>=50000/mm^3;aspartate
             aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase <=2.5
             x ULN; total bilirubin <=2.5 x ULN

          -  Normal renal function within 45 days prior to study entry

          -  Willing to use acceptable forms of contraception

          -  Karnofsky performance score >=70 on at least one occasion within 45 days prior to
             study entry

          -  Parent or guardian willing to provide informed consent, if applicable

          -  Planning to remain in the same geographical area of residence and are willing to
             attend study visits as required

        Inclusion Criteria for Trial 1 Participants:

          -  Previously received NVP for prevention of MTCT of HIV

          -  Has documentation of all prior doses of NVP used for prevention of MTCT of HIV

          -  Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study
             entry

        Exclusion Criteria for All Participants:

          -  Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial
             1 participants. Participants who have received up to 10 weeks of zidovudine alone and
             completed this course at least 6 months prior to study entry are not excluded.

          -  Use of systemic cancer chemotherapy, systemic investigational agents,
             immunomodulators, or rifampin within 30 days of study entry

          -  Pregnant or breastfeeding

          -  Known allergy or sensitivity to study drugs or their formulations

          -  Any condition, including drug or alcohol abuse, that, in the opinion of the
             investigator, may interfere with adherence to study regimens

          -  Serious illness requiring systemic treatment or hospitalization. Participants who
             complete therapy or are clinically stable on therapy for at least 30 days prior to
             study entry are not excluded.

          -  Tuberculosis (TB) treatment within 30 days prior to study entry

          -  Use of any prohibited medications within 30 days prior to study entry

          -  Involuntary incarceration in a correctional facility, prison, or jail for legal
             reasons or in a medical facility for treatment of either a psychiatric or physical
             illness