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