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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695422
• Other study ID #: AMC-058
• Secondary ID: U01CA121947CDR00
• Status: Completed
• Start date: May 14, 2008
• Est. completion date: April 19, 2017

Study information

• Verified date: August 2020
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aids-related Malignancies
• Infection
• Lymphoma
• Neoplasms
• Precancerous Condition
• Precancerous Conditions
• Sarcoma
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Genetic:
• polymerase chain reaction
PCR for HPV DNA detection, performed on specimens collected at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.

Other:
• cytology specimen collection procedure
Detection of HPV-associated neoplasia at baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol.
• histological technique
Detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Procedure:
• colposcopic biopsy
Where observed during HRA, collection of tissue for detection of HPV-associated neoplasia at baseline, treatment discontinuation on parent protocol, final visit on parent protocol.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	UCLA Clinical AIDS Research and Education (CARE) Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Benaroya Research Institute at Virginia Mason Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)		Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Primary	Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials		Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Primary	Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies		Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Primary	Changes in anal HPV types present		Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
Primary	Frequency of ASIL		Baseline, treatment discontinuation on parent protocol, final visit on parent protocol