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

18 Years
Open (Enrolling)
Aids-related Malignancies, Lymphoma, Precancerous Condition, Sarcoma

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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



- 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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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)

Outcome Time Frame:

Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol

Safety Issue:


Principal Investigator

J. Michael Berry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

May 2008

Completion Date:

May 2015

Related Keywords:

  • Aids-related Malignancies
  • Lymphoma
  • Precancerous Condition
  • Sarcoma
  • high-grade squamous intraepithelial lesion
  • low-grade squamous intraepithelial lesion
  • human papilloma virus infection
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related Kaposi sarcoma
  • AIDS-related lymphoblastic lymphoma
  • AIDS-related malignancies
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • multicentric Castleman disease
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Neoplasms
  • Lymphoma
  • Precancerous Conditions
  • Warts
  • Papillomavirus Infections
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Baylor University Medical Center - Houston Houston, Texas  77030-2399
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
UCLA Clinical AIDS Research and Education (CARE) Center Los Angeles, California  90024
Boston University Cancer Research Center Boston, Massachusetts  02118
Benaroya Research Institute at Virginia Mason Medical Center Seattle, Washington  98101