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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) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00111943 |
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 |
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HIV Infections Hepatitis B, Chronic |
Drug: 1% tenofovir gel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel |
Estimated Enrollment: | 200 |
Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama, Birmingham | |
Birmingham, Alabama, United States, 35294-0022 | |
United States, New York | |
Bronx-Lebanon Hospital Center | |
Bronx, New York, United States | |
India | |
Jehangir Hospital and Medical Center - National AIDS Research Institute (NARI) Clinic | |
Shivaji Nagar, India |
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 |
Study ID Numbers: | HPTN 059 |
Study First Received: | May 26, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00111943 |
Health Authority: | United States: Food and Drug Administration |
Anti-Infective Agents, Local HIV Seronegativity Tenofovir Vaginal gel |
Microbicide Vaginal Microbicide PMPA |
Sexually Transmitted Diseases, Viral Liver Diseases Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases |
HIV Infections Hepatitis B, Chronic Sexually Transmitted Diseases Hepatitis B Tenofovir DNA Virus Infections Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |