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Clinical Trials

MainTitle

Trial of SAVVY Vaginal Gel and HIV in Nigeria

The recruitment status of this study is unknown.

Verified August 2005

Sponsor
Biosyn

Collaborator
FHI 360
United States Agency for International Development (USAID)

Information provided by (Responsible Party)
Biosyn
ClinicalTrials.gov Identifier
NCT00130078

First received: August 11, 2005
Last updated: September 22, 2005
Last Verified: August 2005
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of SAVVY and HIV in Nigeria

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

Eligibility

Ages Eligible for Study: 18 Years to 35 Years  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Biosyn  
ClinicalTrials.gov Identifier: NCT00130078   History of Changes  
Other Study ID Numbers: 9784  
Study First Received: August 11, 2005  
Last Updated: September 22, 2005  

Keywords provided by Biosyn:

HIV Seronegativity
HIV transmission

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.