Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in… (NCT00695422) | Clinical Trial Compass
CompletedNot Applicable
Detecting Anal and Genital Human Papillomavirus Infection and Squamous Intraepithelial Lesions in HIV-Positive Patients Enrolled in AIDS Cancer Clinical Trials
United States47 participantsStarted 2008-05-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Activity of pharmacotherapeutic agents being investigated in AIDS Malignancy Clinical Trials (AMC) against anogenital human papillomavirus (HPV) infection or anogenital squamous intraepithelial lesions (ASIL)
Timeframe: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
2
Cervical HPV infection and cervical/vulvovaginal disease in women participating in AMC clinical trials
Timeframe: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
3
Changes in cervical HPV infection and cervical/vulvovaginal disease after treatment on AMC studies
Timeframe: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
4
Changes in anal HPV types present
Timeframe: Baseline, every 6 months while on parent protocol, treatment discontinuation on parent protocol, final visit on parent protocol
5
Frequency of ASIL
Timeframe: Baseline, treatment discontinuation on parent protocol, final visit on parent protocol