Trial intelligence / Profile preview

Progestin Contraception Effects in HIV+ and HIV- Women

NCT02103660Phase 4

Key facts

Status: Completed
Start: Apr 2014
Primary completion: Mar 2017
Countries: 1
Sponsor: Centers for Disease Control and Prevention
Modality: Small Molecules

Drugs: avatrombopag
Conditions: unintended pregnancy

Overview

Phase 4, randomised, open-label trial of avatrombopag in unintended pregnancy (2 arms), sponsored by Centers for Disease Control and Prevention. Primary endpoint: HIV viral load in the genital tract at 33 months. Started Apr 2014; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

DMPA Injection
150 mg Depo-Medroxyprogesterone Acetate every 13 weeks
LNG Implant
Levonorgestrel implant (Jadelle)

Who it enrols

Pre-menopausal women aged 18-45 with known HIV status (infected or uninfected) who desire hormonal contraception. Must have regular menstrual cycles and be off hormonal contraception for at least 6 months.

Endpoints

Primary

HIV viral load in the genital tract33 months

Secondary

Inflammatory/immune markers in the genital tract6 months
Contraceptive efficacy in HIV-infected women33 months
Interaction of progestin-based hormonal contraception and antiretroviral therapy33 months

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