The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

Study Overview
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Brief Summary
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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.

Detailed Description
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A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system. Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Official Title
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The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

Conditions
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HIV Positive, Anal Condylomata, Anal Warts, HIV Infections

Intervention / Treatment
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* Drug: Saline
* Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment. | Drug: Saline<br>* 0.5 ml<br>|
| Active Comparator: Gardasil<br>The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment. | Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine<br>* 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.<br>* Other names: GARDASIL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. | Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up. | Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts