Trial of SAVVY and HIV in Ghana

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2005 by Biosyn. Recruitment status was Active, not recruiting

First Received on August 11, 2005. Last Updated on September 7, 2005 History of Changes

Sponsor:	Biosyn
Collaborators:	FHI 360 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 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 Ghana

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

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:	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

FHI 360

United States Agency for International Development (USAID)

Investigators

Study Chair:

Leigh Peterson, PhD

FHI 360

More Information

No publications provided by Biosyn

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Biosyn:

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 May 24, 2012