Trial of SAVVY Vaginal Gel and HIV in Nigeria

This study is currently recruiting participants.

Verified by Biosyn, August 2005

First Received: August 11, 2005 Last Updated: September 22, 2005 History of Changes

Sponsor:	Biosyn
Collaborators:	Family Health International United States Agency for International Development (USAID)
Information provided by:	Biosyn
ClinicalTrials.gov Identifier:	NCT00130078

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial of SAVVY and HIV in Nigeria

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: C 31G

U.S. FDA Resources

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

Family Health International

United States Agency for International Development (USAID)

Investigators

Study Chair:

Paul Feldblum

Family Health International

More Information

No publications provided by Biosyn

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, Olayemi MO, Wang L, Nanda K, Rountree W. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS ONE. 2008 Jan 23;3(1):e1474.

Study ID Numbers:	9784
Study First Received:	August 11, 2005
Last Updated:	September 22, 2005
ClinicalTrials.gov Identifier:	NCT00130078 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosyn:

HIV Seronegativity
HIV transmission

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010