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Vaccines

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.

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.

Saline

0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Steven R Hunt, MD

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.

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

The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

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

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.

Washington University School of Medicine

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

Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.

Placebo

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.

Treatment Group

Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.

Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.

Gardasil

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

Compliance with follow up was an ongoing issue.

Steven Hunt, MD

Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.

Placebo Group

Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.

Gardasil Group

Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.

Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.

The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata	NCT00941889	HIV Positive Anal Condylomat... Anal Warts HIV Infections	Saline Quadrivalent Hu...	18 Years -	Washington University School of Medicine
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata	NCT00941889	HIV Positive Anal Condylomat... Anal Warts HIV Infections	Saline Quadrivalent Hu...	18 Years -	Washington University School of Medicine

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