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

Sponsor:

Collaborators:

FHI 360

United States Agency for International Development (USAID)

Information provided by:

Biosyn

ClinicalTrials.gov Identifier:

NCT00129532

First received: August 11, 2005

Last updated: September 7, 2005

Last verified: August 2005

History of Changes

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:

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 (Adult)
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

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: 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

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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