Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysis, Diagnostic18 and overAMC-058
NCI-2009-00393, CDR0000590397, NCT00695422

Trial Description

Summary

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. 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.

Further Study Information

PRIMARY OBJECTIVES:

I. 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.

II. To describe changes in the types of anal HPV present and the prevalence of ASIL in patients treated on these studies.

III. To evaluate cervical HPV infection and cervical/vulvovaginal disease in HIV-positive women participating in these trials.

IV. To describe changes in cervical HPV infection and cervical/vulvovaginal disease in these women after undergoing various study treatments.

SECONDARY OBJECTIVES:

I. For subjects who agree to donate additional specimens to the ACSR, specimens will be stored for future correlative studies to evaluate disease pathogenesis and biomarkers of therapeutic response in HPV-associated neoplasia.

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 (DREs) 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.

Eligibility Criteria

Inclusion Criteria:

Life expectancy >= 3 months

No bleeding disorder or requirement for anticoagulation that would contraindicate any biopsy of the anal canal

Able to understand and willing to sign a written informed consent document

Patients receiving myelosuppressive therapy must meet the following criteria:

ANC > 1,000/microL;

Platelet count > 50,000/microL;

Evaluated before treatment or completely recovered from their nadir

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

ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%

Not pregnant or nursing

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

AIDS Malignancy Consortium

  • National Cancer Institute
J. Michael Berry, Principal Investigator

Trial Sites

U.S.A.

California
La Jolla

UC San Diego Moores Cancer Center

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Los Angeles

UCLA Center for Clinical AIDS Research and Education

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Hawaii
Honolulu

Cancer Center of Hawaii-Hawaii AIDS Clinical Research Program

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Maryland
Rockville

AIDS Malignancy Consortium

J. Michael Berry
Ph: 415-353-7443
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

New York
New York

Memorial Sloan Kettering-Rockefeller Outpatient Pavilion

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Memorial Sloan-Kettering Cancer Center

J. Michael Berry
Ph: 415-353-7443
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Texas
Houston

Thomas Street Clinic

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Washington
Seattle

Virginia Mason Medical Center

J. Michael Berry
Email: jmichael.berry@ucsf.edu

J. Michael Berry
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00695422

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.