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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Hepatitis B, Chronic
Drug: 1% tenofovir gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Adherence to the study gel regimen
  • acceptability of the study gel

Enrollment: 200
Study Completion Date: October 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111943

Locations
United States, Alabama
Alabama Microbicide CRS
Birmingham, Alabama, United States, 35294-0022
United States, New York
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
Bronx, New York, United States
India
NARI Arogya Aadhar Clinic CRS
Pune, Maharashtra, India, 411002
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00111943     History of Changes
Other Study ID Numbers: HPTN 059, 10145
Study First Received: May 26, 2005
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Anti-Infective Agents, Local
HIV Seronegativity
Tenofovir
Vaginal gel
Microbicide
Vaginal Microbicide
PMPA

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Tenofovir
Tenofovir disoproxil
Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on July 08, 2014