Studies for HIV Negative Subjects

HPTN 066 – Dose-Proportionality & Intra-Individual Variability Of Intracellular Tenofovir Diphosphate & Emtricitabine Triphosphate In Healthy Volunteers

Question: How much Truvada reaches the blood plasma & genital tract of HIV-negative healthy volunteers, and how long does it stay in these areas?
Population: 16 healthy males, and 16 healthy females.
Medication: Truvada, randomized dosing, intensive & non-intensive sampling schemas.
Duration: Approximately 2 months of outpatient visits.
Call: Heather Prince 919-843-6848

Question: To characterize the amount of raltegravir in the rectal mucosal tissue of HIV-uninfected healthy males.
Population: 14 HIV uninfected, healthy, male volunteers ≥18 and ≤49 years.
Medication: Raltegravir twice daily for 7 days
Duration: 2-18hr PK visits, plus screening and follow up
Call: Heather Prince 843-6848 or Trent Stevens 966-8353

Question:Study the molecular basis of HIV resistance in vivo using humanized mice reconstituted with hematopoietic stem cells from individuals.
Population: 6 healthy men & women ≥ 18 years who meet the protocol definition for being exposed to and at risk for the acquisition HIV.
Medication: G-CSF 5 mcg/kg SQ 2x a day, for 5 days prior to a scheduled leukapheresis.
Duration: 10 days from enrollment through follow up visit (4 study visits).
Call: JoAnn Kuruc 919-966-8533