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

Not Applicable

Completed

Interventions: Drug: Saline
Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	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.
Gardasil	Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine	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.

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.	Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment	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.

Secondary Outcome Measures