The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata (NCT00941889) | Clinical Trial Compass
CompletedNot Applicable
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
United States32 participantsStarted 2007-07
Plain-language summary
The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.
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.
Inclusion Criteria:
* ≥18 years of age;
* HIV positive status;
* CD4 \> 200 and viral RNA \< 400 on anti-retroviral therapy (HAART) or CD4 \> 350 if not on HARRT;
* the presence of anal warts that require surgical excision/ablation.
Exclusion Criteria:
* CD4 \< 200 and/or viral RNA \> 400 on HAART or CD4 \< 350 and not on HAART ;
* low burden of anal warts that would not require surgical excision/ablation;
* previous vaccinations against HPV or allergic reactions to any vaccine component;
* patients who are currently pregnant;
* patients with a previous diagnosis of anal cancer;
* patients who are incarcerated;
* patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;
* patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;
* patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;
* failure to strictly comply with the vaccination schedule.
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
The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.
Timeframe: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment