A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy
Completed
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase 2
2013-06-01
The use of hormone contraception poses a significant challenge for the estimated 16 million
HIV-infected women of childbearing age. This is due to known drug interactions with
antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception
effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel
subdermal implant, the most widely available hormone implant in low and middle-income
countries, this study will translate its findings into an evidence-based approach to
co-manage these important medications. The investigators hypothesize that women receiving
nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the
mean levonorgestrel plasma concentration measured six months after the implant's insertion as
compared to those women who are not taking antiretroviral therapy. Although the implant's
efficacy may be retained initially, the investigators propose that a decrease in
levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the
implant's effectiveness near the end of its intended duration of use (5 years).
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