IRB 09-2120: TDF/FTC/EFV/ATV/r PK in Aging HIV-Infected Patients
Question: Determine pharmacokinetic differences in Atripla (FTC/TDF/EFV) OR Truvada + boosted Reyataz (FTC/TDF/ATV/r) in HIV-infected subjects as they age
Population: 100 outpatient HIV-1 + adults receiving Atripla OR Truvada + boosted Reyataz without anemia or significant drug interactions, willing to provide multiple blood samples.
Medication: No med provided; must be adherent & receiving med ≥ 2 weeks prior to screening.
Duration: Inpatient: 2 x 2-14 hour outpatient visits with 1-3 blood draws each visit, comleted within 6 months. Length of visits and timing of blood samples flexible.
Call: Heather Prince 919-843-6848; Julie Dumond 919-966-5017
IRB 12-0832: A Phase IV Study of PK and PD Drug Interactions of Raltegravir and Oral Contraceptives
Question: To learn about the potential interactions between raltegravir and a birth control pill in HIV+ women and to establish a standard for investigating PK/PD outcomes of oral contraceptive-antiretroviral interaction studies
Population: 15 HIV+ women, ages 20-40, who are on steady state raltegravir regimens and report regular monthly menses
Medication: Approximately 8 months, both inpatient and outpatient visits
Duration: Heather Prince 843-6848, or Tanja Hadzic 843-8723