Studies for HIV Negative Subjects

IRB 10-1393 -A Phase I Investigation of Single-Dose Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissue and Secretions

    • Question: To evaluate how much of these four ARV's reaches the blood plasma, genital tract and GI tract of HIV negative healthy females
    • Population: 48 healthy premenopausal women, ages 18-49, inclusive
    • Medication: 3 different doses of Emtricitabine/Raltegravir and Maraviroc/Tenofovir
    • Duration: Approximately 2 months, both inpatient and outpatient visits
    • Call: Heather Prince 843-6848

A5311 A Phase I Clinical Trial of the Pharmacokinetics of High-dose Daily Rifapentine, Given as a Single Dose or in Divided Doses to Healthy Volunteers

    • Question: To evaluate two strategies for maximizing daily exposure to rifapentine (RPT)
    • Population: Healthy males and females, ages 18-65
    • Medication: 3 different doses of rifapentine
    • Duration: 63-77 days
    • Call: Becky Straub 919-843-9975

HPTN 069 – NEXT PREP Novel Exploration of Therapeutics for PREP, A phase II randomized, double-blind, study of the safety and tolerability of four antiretroviral drug regiments for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission.

    • Question: To assess the safety and tolerability of Maraviroc (MVC), Maraviroc+ Emtricitabine (FTC), Maraviroc + Tenofovir disoproxil fumarate (TDF), and Tenofovir disoproxil fumarate + Emtricitabine in each study arm.
    • Population: 25 healthy MSM and transgender women.
    • Medication: Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate, & non-intensive sampling schemas.
    • Duration: Approximately 1 year of outpatient visits.
    • Call: Becky Straub 919-843-9975