Overview

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:

Participant gender:

Summary

The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally suppressed, 18-45 years old (inclusive), to evaluate any bidirectional drug-drug interactions (DDIs) between doravirine (DOR)-containing ART and hormonal contraceptive methods. This PK study will enroll women in five distinct groups, each with 21 participants (total of 105 participants), and follow them for approximately 18-30 weeks.

Phase:

Phase 1

Details

Lead Sponsor:

University of Washington

Collaborators:

Merck Sharp & Dohme LLC
Wits Reproductive Health and HIV Institute

Treatments:

Etonogestrel
Medroxyprogesterone
Medroxyprogesterone Acetate