Status:
TERMINATED
Cellulose Sulfate (CS) Gel and HIV in Nigeria
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Lagos State University
University of Port Harcourt Teaching Hospital
Conditions:
HIV Infections
Gonorrhea
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
Detailed Description
This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at hi...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent
- At least 18 years old and not more than 35 years old
- Average of three vaginal coital acts per week with a male partner
- More than one male sexual partner in the last 3 months
- Willing to use study product as directed
- Willing to adhere to follow-up schedule
- Willing to participate in the study for 12 months
- Willing to report self-medication during study participation
- Willing to give urine for pregnancy testing; self-administered vaginal swabs for GC/CT testing; OMT for HIV monthly; finger prick for HIV confirmation if required; and blood draw for syphilis and HIV at baseline, and for HIV at the final visit
- Willing to not use a spermicide, other vaginal contraceptive, or vaginal lubricant during the study
- At least 3 months since end of the last pregnancy
Exclusion
- History of adverse reactions to the study products, including latex
- Pregnant or desire a pregnancy during the 12 months of participation
- Injection drug user
- Gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator
- HIV positive as diagnosed by OraQuick® rapid test
- Participation in any other microbicide research
- Discontinued from the CS study previously
- Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
2160 Patients enrolled
Trial Details
Trial ID
NCT00120770
Start Date
November 1 2004
End Date
March 1 2007
Last Update
February 28 2007
Active Locations (2)
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1
Lagos University, College of Medicine, Center 10151
Lagos, Nigeria
2
University of Port Harcourt Teaching Hospital, Center 10152
Port Harcourt, Nigeria