Safety and Acceptability of a Vaginal Microbicide

Completed · Phase 2

Conditions studied: HIV Infections, Hepatitis B, Chronic

In brief

The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women. Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health.

Key facts

Study ID

NCT00111943

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Expected to finish

2007-10-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected
• Good general health
• Sexually active
• Willing to use acceptable methods of contraception, including male latex condoms for all acts of intercourse
• Willing to undergo all study-related assessments and adhere to the requirements of the study

You may not qualify if…

• Menopausal or postmenopausal
• Hysterectomy
• Abnormal screening results for several gynecologic exams
• Taking or planning to take tenofovir, adefovir, or any other medication for chronic HBV infection
• History of latex allergy
• History of adverse reaction to tenofovir or adefovir
• Use of a diaphragm or spermicide for contraception
• Prior participation in the study
• Prior participation in any vaginal microbicide, spermicide, or other drug study within 30 days of study entry
• Gynecologic surgical procedure within 90 days of study entry
• Illicit injection drug use within 12 months of study entry
• History of vaginal intercourse more than an average of two times per day in the two weeks prior to study screening
• Any other criteria that, in the investigator's opinion, may interfere with the study
• Current pregnancy or previous pregnancy within 90 days of study entry
• Breastfeeding

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
• NARI Arogya Aadhar Clinic CRS — Pune, Maharashtra, India

Full record on ClinicalTrials.gov

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