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Safety and PK of TDF-FTC Releasing IVR Over 28 Days Compared to Placebo
NCT03255915Phase 1Active, not recruiting
- Sponsor
- Oak Crest Institute of Science
- Start
- Sep 2018
- Primary completion
- Sep 2020
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of tenofovir disoproxil fumarate and emtricitabine in human immunodeficiency virus infection (HIV) (2 arms), sponsored by Oak Crest Institute of Science. Primary endpoints: Safety of Vaginal IVRs releasing TDF-FTC by reports of Adverse Events at 6 months, Characterization of pharmacokinetics of TDF-FTC released by an IVR - plasma at 6 months and 2 more. Started Sep 2018; status: active, not recruiting.
02
Drugs
tenofovir disoproxil fumarateemtricitabine
03
Conditions
human immunodeficiency virus infection (HIV)
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