Trial of SAVVY Vaginal Gel and HIV in Nigeria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Biosyn.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00130078
First received: August 11, 2005
Last updated: September 22, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: 1.0% C31G SAVVY vaginal gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of SAVVY and HIV in Nigeria

Resource links provided by NLM:


Further study details as provided by Biosyn:

Primary Outcome Measures:
  • Combined incidence of HIV-1 and HIV-2

Estimated Enrollment: 2142
Study Start Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130078

Contacts
Contact: Paul Feldblum 919 544-7040 ext 237 pfeldblum@fhi.org

Locations
Nigeria
Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan Recruiting
Ibadan, Nigeria
Contact: Rasheed A Bakare, MBBS,FWACP         
Principal Investigator: Rasheed A Bakare, MBBS,FWACP         
Nigerian Institute of Medical Research Recruiting
Lagos, Nigeria
Contact: Adesina Adeiga, DVM, MSc         
Principal Investigator: Adesina Adeiga, DVM, MSc         
Sponsors and Collaborators
Biosyn
FHI 360
United States Agency for International Development (USAID)
Investigators
Study Chair: Paul Feldblum FHI 360
  More Information

No publications provided by Biosyn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00130078     History of Changes
Other Study ID Numbers: 9784
Study First Received: August 11, 2005
Last Updated: September 22, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosyn:
HIV Seronegativity
HIV transmission

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014