Safety and Acceptability of a Vaginal Microbicide
|First Received Date ICMJE||May 26, 2005|
|Last Updated Date||March 26, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator|
|Original Primary Outcome Measures ICMJE
||Macroscopic evidence of damage to the cervical epithelium, vulvar or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator|
|Change History||Complete list of historical versions of study NCT00111943 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Safety and Acceptability of a Vaginal Microbicide|
|Official Title ICMJE||Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel|
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.
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 women, yet the only available female-controlled method of HIV prevention is the female condom. Alternative prevention tools, such as vaginal microbicides, are urgently needed to slow the rapid spread of heterosexual HIV infection.
This study will last 24 weeks, with an additional 10 weeks of follow-up for participants with chronic hepatitis B virus (HBV) infection. Participants will be randomly assigned to one of four arms. Arm A participants will insert a vaginal tenofovir 1% gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm B participants will insert a vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm C participants will insert a vaginal tenofovir 1% gel once daily at bedtime or during the longest period of daily rest. Arm D participants will insert a vaginal placebo gel once daily at bedtime or during the longest period of daily rest.
A medical and menstrual history update, pregnancy test, HIV and sexually transmitted infections (STI) risk reduction counseling, and interview to assess behaviors toward vaginal gel use will occur during all study visits. HIV/STI counseling and testing, urinalysis, and blood collection will occur at study entry and at Week 24. Pelvic exam with colposcopy and vaginal swab collection will occur at study entry and Weeks 4, 12, and 24. For participants with chronic HBV, additional blood will be collected to monitor hepatitis B infection at study entry and Weeks 12, 24, 28, 32, and 36.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Intervention ICMJE||Drug: 1% tenofovir gel|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States, India|
|Removed Location Countries|
|NCT Number ICMJE||NCT00111943|
|Other Study ID Numbers ICMJE||HPTN 059, 10145|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Information Provided By||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||March 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP