Cellulose Sulfate (CS) Gel and HIV in Nigeria

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborators: Lagos State University; University of Port Harcourt Teaching Hospital
• Treatments: Anti-Infective Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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