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

Tracking Information

First Received Date ^ICMJE

August 11, 2005

Last Updated Date

September 7, 2005

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

combined incidence of HIV-1 and HIV-2

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00129532 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of SAVVY and HIV in Ghana

Official Title ^ICMJE

Randomized Controlled Trial of SAVVY and HIV in Ghana

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: 1.0% C31G SAVVY vaginal gel

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

2142

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ghana

Administrative Information

NCT Number ^ICMJE

NCT00129532

Other Study ID Numbers ^ICMJE

9779

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Biosyn

Collaborators ^ICMJE

FHI 360
United States Agency for International Development (USAID)

Investigators ^ICMJE

Study Chair:

Leigh Peterson, PhD

FHI 360

Information Provided By

Biosyn

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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