A Study of Nonoxynol-9 (N-9) and HIV Infection
|ClinicalTrials.gov Identifier: NCT00000926|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Nonoxynol-9||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||4400 participants|
|Official Title:||Phase III Nonoxynol-9 and HIV Infection|
|Actual Study Completion Date :||February 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000926
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|
|Study Chair:||Taha E.Taha|
|Study Chair:||Nancy Padian|