Trial of SAVVY and HIV in Ghana - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 11, 2005

Last Updated Date

September 7, 2005

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

combined incidence of HIV-1 and HIV-2

Original Primary Outcome Measures ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Trial of SAVVY and HIV in Ghana

Official Title ^†

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

HIV Infections

Intervention ^†

Drug: 1.0% C31G SAVVY vaginal gel

Study Arms / Comparison Groups

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

2142

Completion Date

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Ghana

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00129532

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Biosyn

Collaborators ^††

Family Health International
United States Agency for International Development (USAID)

Investigators ^†

Study Chair:

Leigh Peterson, PhD

Family Health International

Information Provided By

Biosyn

Verification Date

August 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.