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Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana

NCT03336346 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2020-02-05

No results posted yet for this study

Summary

The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG) have a 20% or greater change in their ENG plasma levels, compared to women taking no antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking dolutegravir have significantly higher ENG plasma levels than ENG implant users taking efavirenz.

This is a cross-sectional, non-randomized evaluation to compare ENG levels between 3 and 12 months post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2) women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This study will be conducted in Botswana in Southern Africa among women using the ENG implant, and involves a one-time collection of blood and questionnaire.

Conditions

  • Contraceptive Usage
  • HIV Infections
  • Drug Interaction

Interventions

DRUG

dolutegravir

HIV integrase strand transfer inhibitor used in combination ART

DEVICE

ENG implant

Reversible contraception implant

DRUG

Efavirenz

non-nucleoside reverse transcriptase inhibitor used in combination ART

Sponsors & Collaborators

Principal Investigators

  • Carolyn L Westhoff, MD · Columbia University

Eligibility

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

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-10-30
Completion
2019-12-11
FDA Drug
Yes

Countries

  • Botswana

Study Locations

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Entities

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 NCT03336346 on ClinicalTrials.gov