Trial of SAVVY and HIV in Ghana

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Biosyn Family Health International United States Agency for International Development (USAID)
Information provided by:	Biosyn
ClinicalTrials.gov Identifier:	NCT00129532

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 Ghana

Further study details as provided by Biosyn:

Primary Outcome Measures:

combined incidence of HIV-1 and HIV-2

Estimated Enrollment:	2142
Study Start Date:	January 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 of 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: NCT00129532

Locations

Ghana
Noguchi Memorial Institute for Medical Research/University of Ghana
Accra, Ghana
Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology
Kumasi, Ghana

Sponsors and Collaborators

Biosyn

Family Health International

United States Agency for International Development (USAID)

Investigators

Study Chair:

Leigh Peterson, PhD

Family Health International

More Information

Publications indexed to this study:

Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY, Rountree W, Troxler A, Dominik R, Roddy R, Dorflinger L. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS ONE. 2007 Dec 19;2(12):e1312.

Study ID Numbers:	9779
Study First Received:	August 11, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00129532
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosyn:

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 15, 2009