Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART
Status:
Completed
Trial end date:
2016-10-10
Target enrollment:
Participant gender:
Summary
This study was done to look at a method of hormonal birth control, called the NuvaRing, and
specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a
hormonal birth control method (specifically oral pills, patches, and injections) and take
ARVs have shown that ARVs interact with the hormones released by the birth control
medication. These interactions may cause the birth control to be less effective at preventing
pregnancy. There is also concern that hormonal birth control can increase HIV spreading to
others, but more studies are needed to determine if this is true. The investigators did not
know whether the NuvaRing and ARVs interact when they are used together, so this study looked
to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones
released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for
women with HIV infection who are taking ARVs. The study also included HIV-infected women who
were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a
similar group of women not on ARVs.
Vaginal rings are also currently being studied to deliver anti-HIV medications that may
prevent HIV acquisition, and to provide birth control over a longer period of time (more than
1 month). Since vaginal rings will become more commonly used to administer medications, the
investigators wanted to better understand the potential for drug interactions with drugs
given vaginally. This study will also help us understand the potential for drug interactions
between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing.
Additionally, this study will help us understand how hormones released from a vaginal ring
affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of
the female genital tract, and the immune system within the genital tract, all of which may
affect the chances of spreading HIV.
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)