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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000926
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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
HIV Infections
Drug: Nonoxynol-9
Phase 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase III Nonoxynol-9 and HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 4400
Study Completion Date: February 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000926

Locations
United States, North Carolina
Julia Welch
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
Study Chair: Taha E.Taha
Study Chair: Nancy Padian
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000926     History of Changes
Other Study ID Numbers: HIVNET 016 Pilot, 11712, HIVNET 016
Study First Received: November 2, 1999
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Nonoxynol

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nonoxynol
Spermatocidal Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on July 28, 2014