Safety and Acceptability of a Vaginal Microbicide

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)
• Treatments: Anti-Infective Agents; Tenofovir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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