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 (NCT) | NCT00153777 |
| Protocol serial number | C03-090 |
| Sponsor | CONRAD (USA) |
| Funders | US Agency for International Development (USAID): $12M, Bill and Melinda Gates Foundation (USA): $12M |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | International |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Cellulose sulfate |
| Primary outcome measure(s) |
HIV infection (incident) |
| Key secondary outcome measure(s) |
NG infection; CT infection |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
