Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
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ClinicalTrials.gov Identifier: NCT00695422 |
Recruitment Status
:
Completed
First Posted
: June 11, 2008
Last Update Posted
: April 20, 2017
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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 and squamous intraepithelial lesions and help doctors plan better treatment.
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.
Condition or disease | Intervention/treatment |
---|---|
Aids-related Malignancies Lymphoma Precancerous Condition Sarcoma | Genetic: polymerase chain reaction Other: cytology specimen collection procedure Other: histological technique Procedure: colposcopic biopsy |
OBJECTIVES:
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.
Study Type : | Observational |
Actual Enrollment : | 47 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials |
Actual Study Start Date : | May 14, 2008 |
Actual Primary Completion Date : | April 19, 2017 |
Actual Study Completion Date : | April 19, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Specimen Collection
Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
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Genetic: 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.
Other: 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.
Other: histological technique
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.
Procedure: 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.
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- Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL) [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ]
- Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ]
- Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ]
- Changes in anal HPV types present [ Time Frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol ]
- Frequency of ASIL [ Time Frame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695422
United States, California | |
Rebecca and John Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
UCLA Clinical AIDS Research and Education (CARE) Center | |
Los Angeles, California, United States, 90095-1793 | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Hawaii | |
Cancer Research Center of Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Massachusetts | |
Boston University Cancer Research Center | |
Boston, Massachusetts, United States, 02118 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Texas | |
Baylor University Medical Center - Houston | |
Houston, Texas, United States, 77030-2707 | |
United States, Washington | |
Benaroya Research Institute at Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | J. Michael Berry, MD | University of California, San Francisco |
Responsible Party: | AIDS Malignancy Consortium |
ClinicalTrials.gov Identifier: | NCT00695422 History of Changes |
Other Study ID Numbers: |
AMC-058 U01CA121947 ( U.S. NIH Grant/Contract ) CDR0000590397 ( Other Identifier: NCI ) |
First Posted: | June 11, 2008 Key Record Dates |
Last Update Posted: | April 20, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AIDS Malignancy Consortium:
high-grade squamous intraepithelial lesion low-grade squamous intraepithelial lesion human papilloma virus infection AIDS-related diffuse large cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related Kaposi sarcoma |
AIDS-related lymphoblastic lymphoma AIDS-related malignancies AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma AIDS-related small noncleaved cell lymphoma multicentric Castleman disease HIV Infections |
Additional relevant MeSH terms:
Lymphoma Infection Neoplasms Sarcoma Precancerous Conditions Papillomavirus Infections Squamous Intraepithelial Lesions of the Cervix Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms, Connective and Soft Tissue DNA Virus Infections Virus Diseases Tumor Virus Infections Uterine Cervical Dysplasia Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |