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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00695422
First received: June 7, 2008
Last updated: January 6, 2014
Last verified: January 2014

June 7, 2008
January 6, 2014
May 2008
May 2015   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency of ASIL [ Time Frame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol ] [ Designated as safety issue: No ]
  • Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL) [ Designated as safety issue: No ]
  • Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials [ Designated as safety issue: No ]
  • Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies [ Designated as safety issue: No ]
  • Changes in anal HPV types present [ Designated as safety issue: No ]
  • Frequency of ASIL [ Designated as safety issue: No ]
  • Correlative studies of disease pathogenesis and biomarkers of therapeutic response in HPV-associated neoplasia [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00695422 on ClinicalTrials.gov Archive Site
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Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood specimens, anal cytology and biopsy of any lesions observed, cervical cytology and biopsy of any lesions observed.

Non-Probability Sample

This study will enroll patients who are study participants on interventional AMC protocols for diseases other than HPV-associated neoplasia with an accrual goal of 15 patients or more.

  • Aids-related Malignancies
  • Lymphoma
  • Precancerous Condition
  • Sarcoma
  • 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.
Specimen Collection
Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
Interventions:
  • Genetic: polymerase chain reaction
  • Other: cytology specimen collection procedure
  • Other: histological technique
  • Procedure: colposcopic biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: J. Michael Berry, MD 877-827-3222
United States
 
NCT00695422
CDR0000590397, U01CA121947, AMC-058
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: J. Michael Berry, MD University of California, San Francisco
AIDS Malignancy Clinical Trials Consortium
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP