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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00120770
Other study ID # 9757
Secondary ID
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
Est. primary completion date
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


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.
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