Clinical trial NCT00117884: Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Papillomavirus Infections
Keywords: Papillomavirus infections;
Cervix Dysplasia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-07-11
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.

Detailed description: Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.

Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.

Eligibility criteria: Inclusion Criteria:

* Willing to be on acceptable method of birth control
* Have a Pap smear result of LSIL or ASCUS
* Is high risk HPV positive

Exclusion Criteria:

* No evidence of high-grade disease or glandular abnormalities,
* Complete visualization of all lesion margins and the transformation zone,
* No uncontrolled significant medical illness or sexually transmitted infections,
* Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.

Primary outcomes:
measure: Time to clearance of high-risk human papillomavirus infection.
timeFrame: At each visit
Secondary outcomes:
measure: Proportion of subjects with evidence of regression to normal cytology.
timeFrame: Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).
measure: Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).
timeFrame: At each visit
measure: Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.
timeFrame: Visits 1-3 as assigned by group
measure: Time to progression of disease to precancer.
timeFrame: Visits 1-3 as assigned by group
measure: Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).
timeFrame: At each visit
Other outcomes:
Locations:
city: Colton
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Moorestown
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Renton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Quebec
country: Canada
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: