drugset / Trial / NCT02985996
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |