Trial of SAVVY Vaginal Gel and HIV in Nigeria

This study is currently recruiting participants.

Verified by Biosyn, August 2005

Sponsors and Collaborators:	Biosyn 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

MedlinePlus related topics: AIDS

Drug Information available for: C 31G

U.S. FDA Resources

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

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

Publications indexed to this study:

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosyn:

HIV Seronegativity
HIV transmission

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009