Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral
      medications used for the treatment and prevention of HIV/AIDS. This study will examine how
      these medications are processed in the body of people who are HIV-infected, as well as in
      people who are HIV-uninfected.
    

Detailed description: 
      Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are both nucleoside reverse
      transcriptase inhibitors (NRTIs), a class of medications used for the treatment and
      prevention of HIV/AIDS. Analyzing how the body interacts with these medications at the
      cellular level may lead to more effective dosing strategies for both HIV prevention and
      treatment. This study will examine the pharmacokinetics of TDF and FTC at the cellular level
      in HIV-infected people (N=20) and HIV-uninfected people (N=20). HIV-infected participants
      will be allowed to take part in this study only if their doctor already plans to prescribe
      TDF, FTC, and efavirenz (EFV) for their HIV care, regardless of their participation in this
      study. HIV-infected participants will receive Truvada (TDF/FTC) and EFV for the first 30
      days. After Day 30, participants will continue to receive TDF, FTC, and EFV through Day 60,
      under the direction of their physician. HIV-infected participants will remain on their
      therapy throughout the study as part of their HIV care. HIV-uninfected volunteers will
      receive 30 days of Truvada (TDF/FTC).

      The study duration is 60 days. Study visits will occur at baseline and on Days 1, 3, 7, 20,
      30, and 60. At most study visits, participants will undergo blood and urine collection for
      pharmacology studies, a medication history review, and an adverse effects questionnaire.
      HIV-uninfected participants will also attend two additional study visits at Days 35 and 45 -
      while off study medication - for blood and urine collection, adverse effects questionnaires,
      and a medication history review. At varying study visits during the first 30 days, all
      participants will undergo one rectal biopsy, female participants will undergo one cervical
      cell and fluid sampling procedure, and male participants will provide one semen sample. In
      addition to the collections from enrolled participants, study researchers will also analyze
      previously collected and stored blood samples from participants in the "Chemoprophylaxis for
      HIV Prevention in Men (iPrEx)" study, which examined the use of TDF and FTC for the
      prevention of HIV in men who have sex with men (MSM).
    

Intervention name(s): Emtricitabine (FTC); Tenofovir disoproxil fumarate (TDF); Efavirenz (EFV); Truvada
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg once a day; 300 mg once a day; 600 mg once a day; 200 mg emtricitabine + 300 mg TDF once a day
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Seronegativity; Treatment Experienced