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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000926
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nonoxynol-9 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 4400 participants
Masking: Double
Primary Purpose: Prevention
Official Title: Phase III Nonoxynol-9 and HIV Infection
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000926


Locations
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United States, North Carolina
Julia Welch
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Taha E.Taha
Study Chair: Nancy Padian
More Information
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Publications of Results:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000926    
Other Study ID Numbers: HIVNET 016 Pilot
11712 ( Registry Identifier: DAIDS ES )
HIVNET 016
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Nonoxynol
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nonoxynol
Spermatocidal Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male