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NCT00111943 Clinical Trial

Safety and Acceptability of a Vaginal Microbicide

HIV Infections Clinical Trial

Official title:
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00111943
Other study ID # HPTN 059
Secondary ID 10145
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date October 2007

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 1% tenofovir gel

Locations
Country Name City State
India NARI Arogya Aadhar Clinic CRS Pune Maharashtra
United States Alabama Microbicide CRS Birmingham Alabama
United States Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS) Bronx New York

Sponsors (4)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  India, 

References & Publications (5)

Bentley ME, Fullem AM, Tolley EE, Kelly CW, Jogelkar N, Srirak N, Mwafulirwa L, Khumalo-Sakutukwa G, Celentano DD. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004 Jul;94(7):1159-64. — View Citation

D'Cruz OJ, Uckun FM. Clinical development of microbicides for the prevention of HIV infection. Curr Pharm Des. 2004;10(3):315-36. Review. — View Citation

Mantell JE, Myer L, Carballo-Diéguez A, Stein Z, Ramjee G, Morar NS, Harrison PF. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005 Jan;60(2):319-30. Review. — View Citation

Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Mâsse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. — View Citation

Van Damme L. Clinical microbicide research: an overview. Trop Med Int Health. 2004 Dec;9(12):1290-6. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Adherence to the study gel regimen
Secondary acceptability of the study gel
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