Overview

This trial is active, not recruiting.

Conditions aids-related malignancies, lymphoma, precancerous condition, sarcoma
Treatments polymerase chain reaction, cytology specimen collection procedure, histological technique, colposcopic biopsy
Sponsor AIDS Malignancy Consortium
Collaborator National Cancer Institute (NCI)
Start date May 2008
End date August 2020
Trial size 15 participants
Trial identifier NCT00695422, AMC-058, CDR0000590397, U01CA121947

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
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.
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.
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.

Primary Outcomes

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)
time frame: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
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
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
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
Frequency of ASIL
time frame: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator J. Michael Berry, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by AIDS Malignancy Consortium.