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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00941889
First received: July 16, 2009
Last updated: June 13, 2016
Last verified: June 2016
Results First Received: August 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV Positive
Anal Condylomata
Anal Warts
HIV Infections
Interventions: Drug: Saline
Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited during office visits.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
Gardasil Group 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.

Participant Flow:   Overall Study
    Placebo   Gardasil Group
STARTED   17   15 
COMPLETED   5   3 
NOT COMPLETED   12   12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
Gardasil Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
Total Total of all reporting groups

Baseline Measures
   Placebo   Gardasil   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   15   32 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (10)   37  (13)   37  (11) 
Gender 
[Units: Participants]
     
Female   2   0   2 
Male   15   15   30 
Region of Enrollment 
[Units: Participants]
     
United States   17   15   32 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Compliance with follow up was an ongoing issue.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven Hunt, MD
Organization: Washington University
phone: 314-454-7177
e-mail: hunts@wudosis.wustl.edu


Publications:
Reisinger KS, Block SL, Lazcano E, et al. A randomized controlled trial to evaluate the safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in preadolescents and adolescents. The 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3-5


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00941889     History of Changes
Other Study ID Numbers: HRPO 07-0648
Study First Received: July 16, 2009
Results First Received: August 20, 2013
Last Updated: June 13, 2016
Health Authority: United States: Institutional Review Board