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

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.

Conditions

• HIV Infections
• Contraception
• Drug-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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Wits Reproductive Health and HIV Institute

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Anna Wald, MD, MPH · University of Washington

• Thesla Palanee-Phillips, MMed Sci PhD · Wits Reproductive Health and HIV Institute, Research Centre Clinical Research Site

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-17

Primary Completion

2024-02-05

Completion

2024-02-05

FDA Drug

Yes

Countries

• South Africa

Study Locations