Trial of SAVVY Vaginal Gel and HIV in Nigeria

September 22, 2005 updated by: Biosyn

Randomized Controlled Trial of SAVVY and HIV in Nigeria

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Study Type

Interventional

Enrollment

2142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • Recruiting
        • Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan
        • Contact:
          • Rasheed A Bakare, MBBS,FWACP
        • Principal Investigator:
          • Rasheed A Bakare, MBBS,FWACP
      • Lagos, Nigeria
        • Recruiting
        • Nigerian Institute of Medical Research
        • Contact:
          • Adesina Adeiga, DVM, MSc
        • Principal Investigator:
          • Adesina Adeiga, DVM, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 to 35 year old women
  • HIV negative
  • More than one sexual partner in past 3 months
  • Average 3 coital acts per week
  • Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

  • HIV positive
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Combined incidence of HIV-1 and HIV-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosyn

Collaborators

United States Agency for International Development (USAID)
FHI 360

Investigators

  • Study Chair: Paul Feldblum, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (ESTIMATE)

August 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2005

Last Update Submitted That Met QC Criteria

September 22, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9784 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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