Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women

Completed · Phase 2

Conditions studied: HIV Infections

In brief

A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.

Key facts

Study ID

NCT00592124

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

168

Starts

2008-06-01

Expected to finish

2010-07-01

Last updated by the study team

2021-10-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• General good health
• HIV-uninfected
• Normal menstrual cycle. More information can be found in the protocol.
• Creatinine clearance greater than 70 ml/min
• Sexually active. More information can be found in the protocol.
• Normal Pap smear result within 12 months prior to study entry
• Agrees to not participate in other investigational studies
• Willing to use effective forms of contraception. More information can be found in the protocol.

You may not qualify if…

• Adverse reaction to either of the study products
• Adverse reaction to latex
• Currently sexually active with a partner with history of adverse reaction to latex
• More than three sexual partners in the month prior to screening
• Pathologic bone fracture not related to trauma
• Last pregnancy outcome within 90 days or less prior to enrollment
• Gynecologic or genital procedure within 90 days of study entry
• Enrollment in other investigational study within 30 days of study entry
• Nontherapeutic injection drug use within 12 months of screening
• Any social or medical condition that, in the opinion of the investigator, would interfere with the study
• Abnormal laboratory values
• Grade 2 or higher genital lesions, erythema, and/or edema or has any other abnormal physical or pelvic exam finding that, in the opinion of the investigator, would interfere with the study
• Kidney, reproductive, or urinary tract infection requiring treatment. More information on this criterion can be found in the protocol.
• Pregnant, breastfeeding, or intend to become pregnant
• Unwilling to comply with study participation requirements, including attendance at all scheduled study visits
• Per participant report, use of the following at enrollment, and/or anticipated use during the period of study participation - use of a diaphragm, vaginal ring, and/or spermicide for contraception, acyclovir or valacyclovir, post-exposure prophylaxis for HIV exposure, TDF/emtricitabine, non-study vaginal products

Where it is running

• Alabama Microbicide CRS — Birmingham, Alabama, United States
• Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS) — The Bronx, New York, United States
• Case CRS — Cleveland, Ohio, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States
• Botha's Hill CRS — Durban, KwaZulu-Natal, South Africa
• Umkomaas CRS — Durban, KwaZulu-Natal, South Africa
• Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS — Kampala, Uganda

Full record on ClinicalTrials.gov

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