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Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women

NCT00442910 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2010-06-24

No results posted yet for this study

Summary

There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.

Conditions

  • Healthy

Interventions

DRUG

3% SPL7013 Gel (VivaGel)

3% vaginal gel

DRUG

Placebo Gel

Placebo for SPL7013 gel

DRUG

HEC Placebo Gel

HEC Placebo gel intravaginally bd for 14 days

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Microbicide Trials Network

    collaborator NETWORK

  • Starpharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Ian McGowan, MD, PhD · University of California Geffen School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Puerto Rico

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 NCT00442910 on ClinicalTrials.gov