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
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.
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, there is also solid evidence that it decreases the effectiveness of
etonogestrel-releasing implants. This presents a difficult clinical scenario in countries
where the HIV burden is significant in reproductive age women.
Following the SINGLE trial, dolutegravir has replaced efavirenz in many settings as
first-line ART. In 2016, Botswana became the first country in Africa to adopt this as a
guideline, however, the effect that dolutegravir has on hormonal contraceptives has not been
widely studied. This project seeks to understand the interaction between etonogestrel levels
in HIV-infected women who are using dolutegravir-based ART by directly measuring etonogestrel
blood levels using liquid chromatography-mass spectrometry in HIV-negative and HIV-infected
women using contraceptive implants.
Because the implant is fairly new in Botswana, most participants will have had implants
inserted 3-12 months prior to study. An HIV-infected, non-ART, comparison group is no longer
permissible, practically or ethically, as countries across Africa, including Botswana, are
moving to HIV "Test and Treat." This means that ART initiation is now occurring at time of
HIV-diagnosis regardless of cluster of differentiation 4 (CD4) count or disease stage;
therefore, in this study, the comparison group will be HIV-uninfected implant users. This
comparison will answer the key question of whether the ENG implant when used simultaneously
with DTG provides plasma ENG levels comparable to a group in which it has established
contraceptive efficacy (i.e. HIV-uninfected, healthy women of reproductive age).
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