NCT00000926

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,400

participants targeted

Target at P75+ for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Nonoxynol

Interventions

Nonoxynol-9DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julia Welch

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

  • Kumwenda N, Hoffman I, Chirenje M, Kelly C, Coletti A, Ristow A, Martinson F, Brown J, Chilongozi D, Richardson B, Rosenberg Z, Padian N, Taha T. HIV incidence among women of reproductive age in Malawi and Zimbabwe. Sex Transm Dis. 2006 Nov;33(11):646-51. doi: 10.1097/01.olq.0000223283.27142.9f.

    PMID: 16773032RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Nonoxynol

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Taha E.Taha

    STUDY CHAIR

  • Nancy Padian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

February 1, 2001

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(1)