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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 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.


Detailed Summary:

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
Sponsor: AIDS Malignancy Consortium

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
  • Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials
  • Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies
  • Changes in anal HPV types present
  • Frequency of ASIL
  • Correlative studies of disease pathogenesis and biomarkers of therapeutic response in HPV-associated neoplasia


Current Secondary Outcome:

Original Secondary Outcome:

Information By: AIDS Malignancy Consortium

Dates:
Date Received: June 7, 2008
Date Started: May 14, 2008
Date Completion:
Last Updated: April 19, 2017
Last Verified: April 2017