Cellulose Sulfate (CS) Gel and HIV in Nigeria

FHI 360

Status and phase

Terminated

Phase 3

Conditions

Gonorrhea

Chlamydia Infections

HIV Infections

Treatments

Drug: Cellulose Sulfate Vaginal Gel (Microbicide)

Study type

Interventional

Funder types

Other

Identifiers

NCT00120770

9757

Details and patient eligibility

About

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.

Full 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 high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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