Clinical trial NCT00941889: The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
Official title: The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Positive
Anal Condylomata
Anal Warts
HIV Infections
Keywords: HIV
HPV
Anal condylomata
Vaccine
HIV positive patients
Anal condylomata or anal warts
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis, Section of Colon Rectal Surgery
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Steven R Hunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.
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