The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
|ClinicalTrials.gov Identifier: NCT00941889|
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Positive Anal Condylomata Anal Warts HIV Infections||Drug: Saline Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Placebo Comparator: Placebo
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.
Active Comparator: Gardasil
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.
Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.
Other Name: GARDASIL
- The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. [ Time Frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941889
|United States, Missouri|
|Washington University in St. Louis, Section of Colon Rectal Surgery|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Steven R Hunt, MD||Washington University School of Medicine|