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

• Status: Completed
• Trial end date: 2001-02-01
• Target enrollment: 0
• Participant gender: Female

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 population is not likely to use condoms, an HIV-prevention method that women can control is needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Nonoxynol

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.