Trial Information

A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous Intraepithelial Lesions (ASIL) in Subjects Participating in AMC 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.