Cellulose Sulfate (CS) Gel and HIV in Nigeria

HIV Infections Clinical Trial

Official title:

Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00120770
• Other study ID #: 9757
• Status: Terminated
• Phase: Phase 3
• First received: July 11, 2005
• Last updated: February 27, 2007
• Start date: November 2004
• Est. completion date: March 2007

Study information

• Verified date: February 2007
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2160
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Gonorrhea
• HIV Infections
• Infection

Intervention

Drug:
• Cellulose Sulfate Vaginal Gel (Microbicide)

Locations

Country	Name	City	State
Nigeria	Lagos University, College of Medicine, Center 10151	Lagos
Nigeria	University of Port Harcourt Teaching Hospital, Center 10152	Port Harcourt

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	Lagos State University, University of Port Harcourt Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
Secondary	Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.

External Links

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