Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
- Conditions
- Aids-related MalignanciesSarcomaLymphomaPrecancerous Condition
- Interventions
- Genetic: polymerase chain reactionOther: cytology specimen collection procedureOther: histological techniqueProcedure: colposcopic biopsy
- Registration Number
- NCT00695422
- Lead Sponsor
- AIDS Malignancy Consortium
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Specimen Collection colposcopic biopsy Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females. Specimen Collection cytology specimen collection procedure Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females. Specimen Collection histological technique Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females. Specimen Collection polymerase chain reaction Blood collection, anal cytology and biopsy of observed lesions. Additional cervical cytology and biopsy for females.
- Primary Outcome Measures
Name Time Method 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 Frequency of ASIL Baseline, treatment discontinuation on parent protocol, final visit on parent protocol 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 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 Changes in anal HPV types present Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Benaroya Research Institute at Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
UCLA Clinical AIDS Research and Education (CARE) Center
🇺🇸Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States