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

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.

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