drugset / Trial / NCT03197961
Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | medroxyprogesterone acetate | Other / unclassified | 150 mg | Intramuscular |