Status:
COMPLETED
A Study of Nonoxynol-9 (N-9) and HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV. Most of the people with HIV in the world today live in southern Africa. Because this pop...
Detailed Description
Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, di...
Eligibility Criteria
Inclusion Criteria
Volunteers may be eligible if they:
- Are HIV-negative.
- Are sexually active and expect to have vaginal intercourse at least twice a week during the study.
- Are willing to keep a diary of their sexual behavior and N-9 use.
- Are willing to have regular clinic visits including pelvic exams.
- Are at least 18 years old.
- Are female.
Exclusion Criteria
Volunteers will not be eligible if they:
- Have had a child or an abortion in the past 42 days.
- Are allergic to latex or N-9.
- Have genital sores.
- Have syphilis, chlamydia, gonorrhea, or trichomoniasis.
- Are enrolled in another study for a product like N-9.
- Expect to use another vaginal product other than N-9 during the study.
- Are pregnant.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 2001
Estimated Enrollment :
4400 Patients enrolled
Trial Details
Trial ID
NCT00000926
End Date
February 1 2001
Last Update
October 29 2021
Active Locations (1)
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1
Julia Welch
Research Triangle Park, North Carolina, United States, 27709