Safety and Acceptability of a Vaginal Microbicide

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00111943
First received: May 26, 2005
Last updated: March 26, 2012
Last verified: March 2012

May 26, 2005
March 26, 2012
Not Provided
Not Provided
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
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
Complete list of historical versions of study NCT00111943 on ClinicalTrials.gov Archive Site
  • Adherence to the study gel regimen
  • acceptability of the study gel
Same as current
Not Provided
Not Provided
 
Safety and Acceptability of a Vaginal Microbicide
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • Hepatitis B, Chronic
Drug: 1% tenofovir gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2007
Not Provided

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00111943
HPTN 059, 10145
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Sharon Hillier, PhD Department of Obstetrics and Gynecology and Reproductive Sciences, Magee-Women's Hospital
Study Chair: Jessica Justman, MD Bronx-Lebanon Hospital Center
Study Chair: Smita N. Joshi, MBBS National AIDS Research Institute (NARI)
Study Chair: Craig Hoesley, MD University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP