HIV Infections Clinical Trial
Official title:
The Effect of Dolutegravir-based ART on Plasma Etonogestrel Levels in HIV-infected Women Using Contraceptive Implants in Botswana
Verified date | February 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | December 11, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - Exclude women using concomitant enzyme-inducing drugs, including rifampicin for tuberculosis treatment and anti-convulsant medications (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) |
Country | Name | City | State |
---|---|---|---|
Botswana | Botswana-UPenn Partnership | Gaborone |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
Botswana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference (percentage) in ENG plasma levels in the DTG group compared to no ART group | Difference between the DTG group and no ART group | Up to 12 months after implant | |
Secondary | Difference (percentage) in ENG plasma levels in the DTG group compared to EFV group | Difference between the DTG group and EFV group | Up to 12 months after implant |
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