Completed

Phase 3
Age: 18Years +
FEMALE
Healthy Volunteers
ID00000926

Phase III Nonoxynol-9 and HIV Infection

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29

4400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Julia Welch

Research Triangle Park, North Carolina, United States, 27709

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

PREVENTION

Number of Arms

0

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Published Research Related To This Trial