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Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women

NCT02722421 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether increasing the dose of the levonorgestrel subdermal contraceptive implant will overcome a detrimental drug-drug interaction with efavirenz based antiretroviral therapy.

Conditions

  • HIV
  • Contraception

Interventions

DRUG

Levonorgestrel

Increased dose levonorgestrel implant plus efavirenz-based antiretroviral therapy.

DRUG

Efavirenz

Participants will receive efavirenz-based ART as part of standard of care

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Infectious Diseases Institute, Uganda

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Northwestern University Feinberg School of Medicine

    collaborator OTHER

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Kimberly K Scarsi, PharmD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2019-12-05
Completion
2020-03-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT02722421 on ClinicalTrials.gov