HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Efavirenz; Emtricitabine/Tenofovir disoproxil fumarate
Intervention description: 600-mg tablet taken orally daily; 200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if pregnancy-limited, short-term combination HIV
      treatment regimens -- which were used solely for the prevention of mother to child
      transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard
      initial regimen of anti-HIV drugs when subsequent treatment is needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected

          -  Viral load of 500 copies/mL or more

          -  Prior HAART for more than 7 days, but less than 40 weeks during at least one previous
             pregnancy for prevention of MTCT of HIV

          -  Clinical or laboratory indication to start HAART, in the opinion of the participant's
             physician

          -  Certain laboratory values

          -  Willingness to use acceptable forms of contraception

          -  Parent or guardian willing to provide informed consent, if applicable

        Exclusion Criteria:

          -  Taking any antiretroviral medication within 24 weeks prior to study entry

          -  Evidence of certain HIV-1 RT mutations within 90 days prior to study entry (version
             1.0)

          -  Evidence of certain HIV-1 RT mutations identified by standard bulk viral population
             genotypic resistance tests at any time prior to study entry, if available (version
             2.0, 09/03/2009)

          -  Treatment at any time, for any reason with nevirapine as a single agent OR addition of
             any part of the study regimen as a single agent to a failing regimen

          -  Use of certain antihistamines, certain anti-infectives, cisapride, St John's wort,
             midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine
             within 14 days prior to study entry

          -  Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other
             cytokines, or investigational therapy within 30 days prior to study entry

          -  Acute or chronic therapy for certain serious medical illnesses within 14 days of study
             entry. Participants who have completed 7 days of therapy and are judged clinically
             stable are not excluded.

          -  Cancer requiring systemic chemotherapy

          -  Known allergy/sensitivity to the study drugs or their formulations

          -  Current drug or alcohol use that, in the opinion of the investigator, would interfere
             with the study

          -  Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following
             initiation of HAART during pregnancy and while still receiving HAART

          -  Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following
             initiation of HAART during pregnancy while still receiving HAART

          -  Current imprisonment or involuntary incarceration in a medical facility for
             psychiatric or physical illness

          -  Pregnancy or breastfeeding