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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000926 |
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 | Intervention | Phase |
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HIV Infections |
Drug: Nonoxynol-9 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind |
Official Title: | Phase III Nonoxynol-9 and HIV Infection |
Estimated Enrollment: | 4400 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers may be eligible if they:
Exclusion Criteria
Volunteers will not be eligible if they:
Study ID Numbers: | HIVNET 016 |
Study First Received: | November 2, 1999 |
Last Updated: | January 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00000926 |
Health Authority: | United States: Federal Government |
Nonoxynol |
Nonoxynol Virus Diseases Sexually Transmitted Diseases, Viral Octoxynol HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Infection Pharmacologic Actions Therapeutic Uses Lentivirus Infections Antispermatogenic Agents Spermatocidal Agents |