HPTN 066
Status:Completed
Phase:I
Principal Investigator(s):Craig Hendrix, MD, Kristine Patterson, MD, Kenneth Mayer, MD, Adriana Andrade, MD, MPH
Objective:Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.
Prevention Option(s):PrEP
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionOne tablet orally weekly
Mode of DeliveryTablet
ARMsExperimental
DescriptionOne tablet orally twice weekly
Mode of DeliveryTablet
ARMsExperimental
DescriptionTwo tablets orally twice weekly
Mode of Delivery
ARMsExperimental
DescriptionOne tablet orally daily
Mode of Delivery
ARMsExperimental
Official Code:
NCT01276600
Trial Sponsors:
HPTN
Start Date
End Date
January 1, 2011
October 1, 2011
Enrollment:32
Age range:
18 Years ↔
44 Years
Population:Cisgender Men, Cisgender Women