HIV Infections Clinical Trial
Official title:
The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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