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Trial of SAVVY and HIV in Ghana

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ClinicalTrials.gov Identifier: NCT00129532
Recruitment Status : Unknown
Verified August 2005 by Biosyn.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2005
Last Update Posted : September 8, 2005
Sponsor:
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 of 3 coital acts per week
  • Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

  • HIV positive
  • Pregnant
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00129532


Locations
Ghana
Noguchi Memorial Institute for Medical Research/University of Ghana
Accra, Ghana
Komfo Anokye Teaching Hospital/Kwame Nkrumah University of Science and Technology
Kumasi, Ghana
Sponsors and Collaborators
Biosyn
FHI 360
United States Agency for International Development (USAID)
Investigators
Study Chair: Leigh Peterson, PhD FHI 360
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00129532     History of Changes
Other Study ID Numbers: 9779
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: August 2005

Keywords provided by Biosyn:
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