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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Vaccines

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.