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Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women

NCT02103660 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2018-03-19

No results posted yet for this study

Summary

The purpose of this study is to determine the acceptability of randomization to contraceptive options and estimate the effect of progestin contraception on HIV genital shedding and inflammatory/immune perturbations in women who may or may not be on antiretroviral therapy, as well as in HIV-uninfected women controls. It is hypothesized that progestin-containing contraception will lead to inflammatory changes that may affect the local immune activity, influencing HIV acquisition or transmissibility risk.

Conditions

  • HIV
  • Contraception

Interventions

DRUG

Depo-Medroxyprogesterone Acetate

150 mg Depo-Medroxyprogesterone Acetate administered every 13 weeks

DRUG

Progestin Contraceptive (Jadelle)

2 implants containing 75 mg of levonorgestrel will be implanted and will last for up to 5 years

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Jennifer Tang, MD, MSCR · University of North Carolina

  • Lameck Chinula, MD · UNC-Project Lilongwe

  • Athena P Kourtis, MD, PhD, MPH · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-08
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103660 on ClinicalTrials.gov