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Trial of SAVVY Vaginal Gel and HIV in Nigeria

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Phase 3

Locations

Nigeria

Study Type

Interventional

Intervention

1.0% C31G SAVVY vaginal gel

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV transmission

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 18 to 35 year old women HIV negative More than one sexual partner in past 3 months Average 3 coital acts per week Willing to use vaginal gel and condoms for 12 months Exclusion Criteria: HIV positive Pregnant

Sites / Locations

Department of Medical Microbiology & Parasitology, College of Medicine, University of IbadanRecruiting
Nigerian Institute of Medical ResearchRecruiting

Outcomes

Primary Outcome Measures

Combined incidence of HIV-1 and HIV-2

Secondary Outcome Measures

Full Information

NCT ID

NCT00130078

First Posted

August 11, 2005

Last Updated

September 22, 2005

Sponsor

Biosyn

Collaborators

FHI 360, United States Agency for International Development (USAID)

1. Study Identification

Unique Protocol Identification Number

NCT00130078

Brief Title

Trial of SAVVY Vaginal Gel and HIV in Nigeria

Official Title

Randomized Controlled Trial of SAVVY and HIV in Nigeria

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Biosyn

Collaborators

FHI 360, United States Agency for International Development (USAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Seronegativity, HIV transmission

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

2142 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

1.0% C31G SAVVY vaginal gel

Primary Outcome Measure Information:

Title

Combined incidence of HIV-1 and HIV-2

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Feldblum

Phone

919 544-7040

Ext

237

pfeldblum@fhi.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Feldblum

Organizational Affiliation

FHI 360

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan

City

Ibadan

Country

Nigeria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rasheed A Bakare, MBBS,FWACP

First Name & Middle Initial & Last Name & Degree

Rasheed A Bakare, MBBS,FWACP

Facility Name

Nigerian Institute of Medical Research

City

Lagos

Country

Nigeria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adesina Adeiga, DVM, MSc

First Name & Middle Initial & Last Name & Degree

Adesina Adeiga, DVM, MSc

12. IPD Sharing Statement

Citations:

PubMed Identifier

18213382

Citation

Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, Olayemi MO, Wang L, Nanda K, Rountree W. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS One. 2008 Jan 23;3(1):e1474. doi: 10.1371/journal.pone.0001474.

Results Reference

derived

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Trial of SAVVY Vaginal Gel and HIV in Nigeria

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