Trial of SAVVY Vaginal Gel and HIV in Nigeria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Biosyn.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
FHI 360
United States Agency for International Development (USAID)
Information provided by:
Biosyn
ClinicalTrials.gov Identifier:
NCT00130078
First received: August 11, 2005
Last updated: September 22, 2005
Last verified: August 2005

August 11, 2005
September 22, 2005
September 2004
Not Provided
Combined incidence of HIV-1 and HIV-2
Same as current
Complete list of historical versions of study NCT00130078 on ClinicalTrials.gov Archive Site
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Trial of SAVVY Vaginal Gel and HIV in Nigeria
Randomized Controlled Trial of SAVVY and HIV in Nigeria

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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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 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: Paul Feldblum 919 544-7040 ext 237 pfeldblum@fhi.org
Nigeria
 
NCT00130078
9784
Not Provided
Not Provided
Biosyn
  • FHI 360
  • United States Agency for International Development (USAID)
Study Chair: Paul Feldblum FHI 360
Biosyn
August 2005

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