Contact information
Type
Scientific
Contact name
Dr Lut Van Damme
ORCID ID
Contact details
1611 N Kent Street
Suite 806
Arlington
VA
22209
United States of America
+1 703 276 4020
lvandamme@conrad.org
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00153777
Protocol/serial number
C03-090
Study information
Scientific title
Acronym
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.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
International
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
HIV infection
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Cellulose sulfate
Primary outcome measure
HIV infection (incident)
Secondary outcome measures
NG infection; CT infection
Overall study start date
13/06/2005
Overall study end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy women at risk of HIV infection through their own sexual behavior.
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
2574
Participant exclusion criteria
HIV positive women or at risk of HIV through other transmission routes; pregnant women.
Recruitment start date
13/06/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Benin, Burkina Faso, India, South Africa, Uganda, United States of America
Study participating centre
1611 N Kent Street
Arlington, VA
22209
United States of America
Sponsor information
Organisation
CONRAD (USA)
Sponsor details
1611 N Kent Street
Suite 806
Arlington
VA
22209
United States of America
+1 703 524 4744
lvandamme@conrad.org
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
US Agency for International Development (USAID): $12M
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bill and Melinda Gates Foundation (USA): $12M
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/07/2008 | Yes | No | |
| Results article | results | 27/10/2010 | Yes | No |