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Randomised Controlled Trial of 6% Cellulose Sulfate (CF) Gel and the Effect on Vaginal Human Immunodeficiency Virus (HIV) Transmission
ISRCTN ISRCTN95638385
DOI 10.1186/ISRCTN95638385
ClinicalTrials.gov identifier NCT00153777
EudraCT number
Public title Randomised Controlled Trial of 6% Cellulose Sulfate (CF) Gel and the Effect on Vaginal Human Immunodeficiency Virus (HIV) Transmission
Scientific title
Acronym N/A
Serial number at source C03-090
Study hypothesis Effect on vaginal male-to-female transmission of HIV/Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Null hypotheses (of no effect) are tested.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Benin, Burkina Faso, India, South Africa, Uganda
Disease/condition/study domain HIV infection
Participants - inclusion criteria Healthy women at risk of HIV infection through their own sexual behavior.
Participants - exclusion criteria HIV positive women or at risk of HIV through other transmission routes; pregnant women.
Anticipated start date 13/06/2005
Anticipated end date 31/01/2007
Status of trial Completed
Patient information material
Target number of participants 2574
Interventions Randomized to 6% CS gel or Placebo gel; both arms receive condoms and safer sex counseling. Any curable sexually transmitted infection (STI) or urinary tract infection (UTI) will be treated. Referrals for other conditions. Three monthly gynecological exam with STI testing.
Primary outcome measure(s) HIV infection (incident)
Secondary outcome measure(s) NG infection; CT infection
Sources of funding US Agency for International Development (USAID): $12M
Bill and Melinda Gates Foundation (USA): $12M
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18669425
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21048963
Contact name Dr  Lut  Van Damme
  Address 1611 N Kent Street
Suite 806
  City/town Arlington, VA
  Zip/Postcode 22209
  Country United States of America
  Tel +1 703 276 4020
  Fax +1 703 524 4770
  Email lvandamme@conrad.org
Sponsor CONRAD (USA)
  Address 1611 N Kent Street
Suite 806
  City/town Arlington, VA
  Zip/Postcode 22209
  Country United States of America
  Tel +1 703 524 4744
  Fax +1 703 524 4770
  Email lvandamme@conrad.org
  Sponsor website: http://www.conrad.org
Date applied 03/06/2005
Last edited 09/03/2011
Date ISRCTN assigned 08/07/2005
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