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Safety and Acceptability of a Vaginal Microbicide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00111943
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : March 27, 2012
Information provided by (Responsible Party):

Study Description
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 safe and well tolerated in HIV uninfected women who are in good general health.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Adherence to the study gel regimen
  2. acceptability of the study gel

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111943

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
NARI Arogya Aadhar Clinic CRS
Pune, Maharashtra, India, 411002
Sponsors and Collaborators
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
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00111943     History of Changes
Other Study ID Numbers: HPTN 059
10145 ( Registry Identifier: DAIDS ES )
First Posted: May 27, 2005    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
HIV Infections
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
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Anti-Infective Agents
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents