Status:
COMPLETED
Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Aids-related Malignancies
Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Diagnostic procedures, such as anal swab collection, digital rectal examination, and anal endoscopy and biopsy, may help find and diagnose anal and genital human papillomavirus infection an...
Detailed Description
OBJECTIVES: Primary * To determine if various pharmacotherapeutic agents investigated in primary AIDS Malignancy Clinical Trials (AMC) for diseases other than human papillomavirus (HPV)-associated n...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Serologic documentation of HIV infection by any FDA-approved tests
- Enrolled in an AIDS Malignancy Clinical Trials Consortium (AMC) clinical trial of any new or existing pharmacotherapeutic agent for treatment of disease other than human papillomavirus (HPV)-associated neoplasia
- AMC study must have an accrual target of \> 15 patients
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
- Life expectancy ≥ 3 months
- Not pregnant or nursing
- Patients receiving myelosuppressive therapy must meet the following criteria:
- ANC \> 1,000/μL
- Platelet count \> 50,000/μL
- Evaluated before treatment or completely recovered from their nadir
- Able to understand and willing to sign a written informed consent document
- No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
May 14 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00695422
Start Date
May 14 2008
End Date
April 19 2017
Last Update
August 10 2020
Active Locations (10)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
4
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115