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Cellulose Sulfate (CS) Gel and HIV in Nigeria

This study has been terminated.
(The study was halted in January 2007 due to safety concerns.)
Sponsor:
Collaborators:
Lagos State University
University of Port Harcourt Teaching Hospital
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00120770
First received: July 11, 2005
Last updated: February 27, 2007
Last verified: February 2007

July 11, 2005
February 27, 2007
November 2004
Not Provided
Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
Same as current
Complete list of historical versions of study NCT00120770 on ClinicalTrials.gov Archive Site
Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
Same as current
Not Provided
Not Provided
 
Cellulose Sulfate (CS) Gel and HIV in Nigeria
Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • Gonorrhea
  • Chlamydia Infections
Drug: Cellulose Sulfate Vaginal Gel (Microbicide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2160
March 2007
Not Provided

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Nigeria
 
NCT00120770
9757
Not Provided
Not Provided
FHI 360
  • Lagos State University
  • University of Port Harcourt Teaching Hospital
Study Director: Vera Halpern, MD FHI 360
FHI 360
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP