Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Emtricitabine/Tenofovir Disoproxil Fumarate; Lamivudine/Zidovudine; Lopinavir/Ritonavir; single dose Nevirapine
Intervention description: 200mg/300mg as one tablet taken orally once daily; 150mg/300mg as one tablet taken orally twice daily; 133.3mg/33.3mg as three capsules taken orally twice daily; one 200 mg tablet taken orally
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Nevirapine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine, zidovudine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 484.0
Sex: Female
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Treatment Naive

Summary:

      HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to
      prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance
      in the mother, potentially ruling out some treatment options in the future. The purpose of
      this study is to determine which of three anti-HIV drug regimens most effectively reduces the
      development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of
      short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.

      The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral
      therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than
      intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of
      lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or
      lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase
      inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.
    

Eligibility criteria:

        Inclusion Criteria for Mothers:

          -  HIV-1 infected

          -  CD4 count 250 cells/mm3 or greater within 30 days of study entry

          -  The following laboratory values obtained within 30 days prior to study entry: absolute
             neutropil count >= 750/mm3; hemoglobin >= 8.0 g/dL; platelet count >= 50,000/mm3;
             calculated creatinine clearance (Cockcroft-Gault formula) > 60 mL/min; AST(SGOT) and
             ALT(SGPT) < 5 x ULN; total bilirubin < 1.5 X ULN.

          -  Pregnant with a viable fetus at 28 to 38 weeks gestation at study entry.

          -  Willing to give birth to baby in a hospital or clinic

          -  Written informed consent from parent or guardian, if applicable

        Exclusion Criteria for Mothers:

          -  Any ART, including single-dose NVP, prior to study entry. Mothers who receive ZDV
             monotherapy prior to labor under the supervision of the site investigator are not
             excluded.

          -  Known allergy or sensitivity to study drugs or their formulations

          -  Current drug or alcohol abuse that may interfere with the study

          -  Serious illness requiring systemic treatment or hospitalization. Participants who
             complete therapy or are clinically stable on therapy for at least 14 days prior to
             study entry are not excluded.

          -  Hepatitis B surface antigen positive within 180 days prior to study entry

          -  Active tuberculosis infection requiring treatment

          -  Prior enrollment in this study

          -  Expect to use ART, except ZDV monotherapy, prior to onset of labor

          -  Expect to use ART other than study medications from delivery to 9 weeks postpartum