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Trial of SAVVY and HIV in Ghana

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Biosyn.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00129532
First received: August 11, 2005
Last updated: September 7, 2005
Last verified: August 2005

August 11, 2005
September 7, 2005
January 2004
Not Provided
combined incidence of HIV-1 and HIV-2
Same as current
Complete list of historical versions of study NCT00129532 on ClinicalTrials.gov Archive Site
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Not Provided
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Trial of SAVVY and HIV in Ghana
Randomized Controlled Trial of SAVVY and HIV in Ghana

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: 1.0% C31G SAVVY vaginal gel
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2142
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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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Ghana
 
NCT00129532
9779
Not Provided
Not Provided
Biosyn
  • FHI 360
  • United States Agency for International Development (USAID)
Study Chair: Leigh Peterson, PhD FHI 360
Biosyn
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP