A Study of the Effects of Advantage 24 on the Rectum

NCT00000929 | Completed Phase 1 DMC

• 2 other identifiers: HIVNET 00811715
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if it is safe and acceptable for homosexual male couples, where both partners have the same HIV status, to use Advantage 24 during anal intercourse. Advantage 24 is a spermicide (a chemical that kills sperm). Much research and development is being done with chemicals that can be controlled by the receptive partner to prevent the spread of HIV and other sexually transmitted diseases (STDs). Advantage 24 currently is used in the vagina as a form of birth control. The safety of Advantage 24 is particularly important for HIV-positive men because they have a greater chance of serious reaction to Advantage 24 due to other HIV-related conditions.

Conditions

HIV Infections

Keywords

Sexual Partners; Homosexuality, Male; Anti-Infective Agents; Patient Compliance; Nonoxynol; Rectum

Interventions

Nonoxynol-9 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Co-existing Condition:
• Participants with the following symptoms or conditions are excluded:
• Positive HSV-2 serology (HIV-negative participants only).
• Positive syphilis by Venereal Disease Research Laboratory (VDRL) serology and Fluorescent Treponemal Antibody (FTA) or Microhemagglutination Assay (MHA).
• Receptive partners with the following additional symptoms or conditions are excluded:
• Rectal gonorrhea or chlamydia by culture.
• Active rectal inflammation, ulceration, or fissures.
• Insertive partners with the following additional symptoms or conditions are excluded:
• Penile or urethral irritation, rashes, or lesions.
• Penile or scrotal piercing.
• Concurrent Medication:
• Excluded for receptive partners:
• Anticoagulant, including warfarin and heparin.
• Participants with the following prior conditions are excluded:
• Sensitivity or irritative symptoms when using N-9 or when exposed to latex.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections; Homosexuality, Male; Patient Compliance

Interventions

Nonoxynol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Homosexuality; Sexuality; Sexual Behavior; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Connie Celum

  STUDY CHAIR

• Susan Buchbinder

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1999
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (1)