drugset / Trial / NCT03197961

Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP

NCT03197961

Phase 0 Completed 15 enrolled Sharon Achilles
NaSequentialOpen-labelOther

Summary

This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women aged 18-45 who are HIV-negative and at low risk for acquiring HIV.

Timeline

Start
2017-11-17
Primary completion
2018-04-18
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir disoproxil fumarate Small molecule 300 mg Oral
Subject emtricitabine Other / unclassified 200 mg Oral
Subject medroxyprogesterone acetate Other / unclassified 150 mg Intramuscular