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Safety of Acidform Lubricant in HIV-Uninfected Women

NCT00850837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-12-03

No results posted yet for this study

Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.

Conditions

  • HIV Infections

Interventions

DRUG

Acidform Lubricant

5 g application of acid buffered gel (pH = 3.5)

DRUG

HEC gel

5 g application of hydroxyethylcellulose gel

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Marla Keller, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850837 on ClinicalTrials.gov