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

• 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 ]
  

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.