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

Completed · Not applicable · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00941889

Run by

Washington University School of Medicine

People needed

32

Starts

2007-07-01

Expected to finish

2011-07-01

Last updated by the study team

2016-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• Washington University in St. Louis, Section of Colon Rectal Surgery — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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