A Study of Nonoxynol-9 (N-9) and HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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, dictate the need for prophylactic methods women can control.

This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate ...

Gender

FEMALE

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.

Trial Officials