Status:
COMPLETED
Safety and Acceptability of a Vaginal Microbicide
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Hepatitis B, Chronic
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief 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...
Detailed Description
While the male condom is effective in preventing sexual transmission of HIV, its use is hampered by deeply rooted cultural and social barriers. About half of all HIV infections worldwide occur in wome...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00111943
End Date
October 1 2007
Last Update
November 1 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Microbicide CRS
Birmingham, Alabama, United States, 35294-0022
2
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
The Bronx, New York, United States
3
NARI Arogya Aadhar Clinic CRS
Pune, Maharashtra, India, 411002