Randomised Controlled Trial of 6% Cellulose Sulfate (CF) Gel and the Effect on Vaginal Human Immunodeficiency Virus (HIV) Transmission
| ISRCTN | ISRCTN95638385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95638385 |
| ClinicalTrials.gov number | NCT00153777 |
| Secondary identifying numbers | C03-090 |
- Submission date
- 03/06/2005
- Registration date
- 08/07/2005
- Last edited
- 09/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lut Van Damme
Scientific
Scientific
1611 N Kent Street
Suite 806
Arlington, VA
22209
United States of America
| Phone | +1 703 276 4020 |
|---|---|
| lvandamme@conrad.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | International |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2574 |
| Key inclusion criteria | Healthy women at risk of HIV infection through their own sexual behavior. |
| Key exclusion criteria | HIV positive women or at risk of HIV through other transmission routes; pregnant women. |
| Date of first enrolment | 13/06/2005 |
| Date of final enrolment | 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
22209
United States of America
Sponsor information
CONRAD (USA)
Government
Government
1611 N Kent Street
Suite 806
Arlington, VA
22209
United States of America
| Phone | +1 703 524 4744 |
|---|---|
| lvandamme@conrad.org | |
| Website | http://www.conrad.org |
Funders
Funder type
Government
US Agency for International Development (USAID): $12M
No information available
Bill and Melinda Gates Foundation (USA): $12M
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
