drugset / Trial / NCT02985996

Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities

NCT02985996

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.

Timeline

Start
2017-02-06
Primary completion
2017-11-29
Completion
2017-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobicistat Small molecule 150 mg
Subject Tenofovir disoproxil fumarate Small molecule 300 mg
Subject elvitegravir Small molecule 150 mg
Subject emtricitabine Other / unclassified 200 mg
Subject tenofovir alafenamid Unknown 10 mg