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.

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.

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.

No outcomes data were collected or analyzed due to lack of participant follow-up.

Baseline characteristics were reported (age, gender, region of enrollment). Five of 17 patients in the placebo group completed study follow-up through at least 6 months and received all three study injections. Seven of 15 patients in the Gardasil group completed study follow-up through at least 6 months and received all three study injections.

Serious and/or other non-serious adverse events were not collected or assessed.

Compliance with follow up was an ongoing issue.