HIV Infections Clinical Trial
Official title:
Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep)
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.
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).
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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