Phase III Nonoxynol-9 and HIV Infection
Nonoxynol-9
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
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 in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.4400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location