Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
NCT ID: NCT00695422
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2008-05-14
2017-04-19
Brief Summary
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PURPOSE: This clinical trial is studying ways to detect anal and genital human papillomavirus infection and squamous intraepithelial lesions in HIV-positive patients enrolled in an AIDS cancer clinical trial.
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Detailed Description
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Primary
* To determine if various pharmacotherapeutic agents investigated in primary AIDS Malignancy Clinical Trials (AMC) for diseases other than human papillomavirus (HPV)-associated neoplasia have any preliminary evidence of activity against anogenital HPV infection or anogenital squamous intraepithelial lesions (ASIL) in HIV-positive patients participating in these trials.
* To describe changes in the types of anal HPV present and the prevalence of ASIL in patients treated on these studies.
* To evaluate cervical HPV infection and cervical/vulvovaginal disease in HIV-positive women participating in these trials.
* To describe changes in cervical HPV infection and cervical/vulvovaginal disease in these women after undergoing various study treatments.
OUTLINE: This is a multicenter study.
Patients undergo anal swab collection at baseline to obtain samples for anal cytology, anal human papillomavirus (HPV) typing, and other HPV-related testing (e.g., HPV viral load). Digital rectal examinations (DRE) are also performed as part of the baseline physical examination. Female patients also undergo cervical swab collection for cervical HPV testing and cytology, as well as colposcopy (if available) of the cervix and vulvovaginal region to completely assess lower genital tract HPV-related lesions. At sites where high-resolution anoscopy (HRA) is available, patients are encouraged, but not required, to have an HRA with biopsy of any visualized lesions within 30 days of collection of the swabs.
After baseline assessments, patients undergo treatment with the investigative agent according to the study protocol requirements. If study treatment continues beyond 6 months, additional anal and cervical swabs are obtained for anal and cervical HPV and cytology along with DREs every 6 months until completion of study treatment and at the final study visit. Patients may also undergo additional HRA with biopsy and/or colposcopy of the lower genital tract with biopsy (women only) at this time. Patients with an abnormal anal cytology or histology are referred for HRA per local standard of care. If HRA is not available at the treatment site, patients undergo a DRE, and those with an abnormal DRE are referred for evaluation by a surgeon.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Specimen Collection
Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
polymerase chain reaction
PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
cytology specimen collection procedure
Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
histological technique
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
colposcopic biopsy
Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
Interventions
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polymerase chain reaction
PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
cytology specimen collection procedure
Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
histological technique
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
colposcopic biopsy
Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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J. Michael Berry, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CDR0000590397
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-058
Identifier Type: -
Identifier Source: org_study_id
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