Status:
COMPLETED
Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Lead Sponsor:
Columbia University
Conditions:
Contraceptive Usage
HIV Infections
Eligibility:
FEMALE
18-45 years
Brief 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 (...
Detailed Description
Efavirenz-based antiretroviral therapy is effective in treating HIV and had become standard in the World Health Organization (WHO) guidelines. However, despite its effectiveness in lowering viral load...
Eligibility Criteria
Inclusion
- Etonogestrel implant as their sole method of hormonal contraception
- Etonogestrel implant in-situ for three to twelve months.
- Dolutegravir (DTG) use for at least 60 days (Using DTG-based ART-regimen if applicable)
- Efavirenz (EFV) use for at least 60 days (Using EFV-based ART-regimen if applicable)
Exclusion
- Exclude women using concomitant enzyme-inducing drugs, including rifampicin for tuberculosis treatment and anti-convulsant medications (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)
Key Trial Info
Start Date :
November 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03336346
Start Date
November 15 2017
End Date
December 11 2019
Last Update
February 5 2020
Active Locations (1)
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1
Botswana-UPenn Partnership
Gaborone, Botswana