NCT00130078

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,142

participants targeted

Target at P75+ for phase_3 hiv-infections

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
Last Updated

September 26, 2005

Status Verified

August 1, 2005

First QC Date

August 11, 2005

Last Update Submit

September 22, 2005

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV transmission

Outcome Measures

Primary Outcomes (1)

  • Combined incidence of HIV-1 and HIV-2

Interventions

1.0% C31G SAVVY vaginal gelDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • HIV positive
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Ibadan, Nigeria

RECRUITING

Nigerian Institute of Medical Research

Lagos, Nigeria

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18213382DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Paul Feldblum

    FHI 360

    STUDY CHAIR

Central Study Contacts

Paul Feldblum

CONTACT

919 544-7040pfeldblum@fhi.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

September 1, 2004

Last Updated

September 26, 2005

Record last verified: 2005-08

Locations

NG(2)