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Trial of SAVVY Vaginal Gel and HIV in Nigeria

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ClinicalTrials.gov Identifier: NCT00130078
Recruitment Status : Unknown
Verified August 2005 by Biosyn.
Recruitment status was:  Recruiting
First Posted : August 15, 2005
Last Update Posted : September 26, 2005
Sponsor:
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: 1.0% C31G SAVVY vaginal gel Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 2142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of SAVVY and HIV in Nigeria
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources




Primary Outcome Measures :
  1. Combined incidence of HIV-1 and HIV-2


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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 3 coital acts per week
  • Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

  • HIV positive
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130078


Contacts
Contact: Paul Feldblum 919 544-7040 ext 237 pfeldblum@fhi.org

Locations
Nigeria
Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan Recruiting
Ibadan, Nigeria
Contact: Rasheed A Bakare, MBBS,FWACP         
Principal Investigator: Rasheed A Bakare, MBBS,FWACP         
Nigerian Institute of Medical Research Recruiting
Lagos, Nigeria
Contact: Adesina Adeiga, DVM, MSc         
Principal Investigator: Adesina Adeiga, DVM, MSc         
Sponsors and Collaborators
Biosyn
FHI 360
United States Agency for International Development (USAID)
Investigators
Study Chair: Paul Feldblum FHI 360

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00130078     History of Changes
Other Study ID Numbers: 9784
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: September 26, 2005
Last Verified: August 2005

Keywords provided by Biosyn:
HIV Seronegativity
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