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

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

November 17, 2021

Primary Completion Date

February 5, 2024

Study Completion Date

February 5, 2024

Conditions
HIV InfectionsContraceptionDrug-drug Interaction
Interventions
DRUG

Etonogestrel (ETG) implant

Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.

DRUG

Intramuscular depo-medroxyprogesterone acetate (IM DMPA)

DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.

DRUG

Sub-cutaneous medroxyprogesterone acetate (SC MPA)

SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.

DEVICE

Non-hormonal intrauterine device (IUD)

The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.

Trial Locations (1)

2001

Wits Reproductive Health and HIV Institute, Research Centre Clinical Research Site, Johannesburg

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Wits Reproductive Health and HIV Institute

OTHER

collaborator

University of Washington

OTHER

lead

University of Alabama at Birmingham

OTHER

NCT04669678 - Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa | Biotech Hunter | Biotech Hunter