HIV Clinical Trial
Official title:
Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir With and Without Levonorgestrel Among Women in Western Kenya
The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.
This Phase 2a clinical trial will evaluate the safety, pharmacokinetics and pharmacodynamics
of, and the tolerability and adherence to two novel intravaginal rings (IVRs). The
tenofovir/levonorgestrel (TFV/LNG) IVR and TFV IVRs are designed to provide HIV (and HSV-2)
prevention with and without contraceptive for pregnancy prevention, respectively. Women will
be protected from pregnancy by abstinence from vaginal intercourse or agreeing to
consistently use condoms; concurrent use of a non-hormonal copper intrauterine device is
permitted.
The study will enroll healthy, HIV-negative, non-pregnant, menstruating women aged 18-34
years, inclusive, and not currently infected with hepatitis B virus, who are assessed to be
at lower risk for HIV. The goal is to enroll fifty (50) women in Western Kenya. The
participants will be randomized 2:2:1 to use one of the following continuous delivery IVRs:
twenty (20) women to use the TFV/LNG IVR; ten (10) women to use the TFV IVR; and ten (10)
women to use the placebo IVR. Participants will attend up to ten (10) routine study visits
that may include physical and pelvic exams, collection of venous blood, vaginal fluid and
cervical mucus, and behavioral questionnaires. A subset of twenty (20) women will participate
in in-depth interviews.
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