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Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00513526
First received: August 6, 2007
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
Results First Received: June 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infection
Precancerous Condition
Intervention: Biological: Gardasil

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gardasil Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Participant Flow:   Overall Study
    Gardasil  
STARTED     109  
COMPLETED     92  
NOT COMPLETED     17  



  Baseline Characteristics
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Reporting Groups
  Description
Gardasil Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Baseline Measures
    Gardasil  
Number of Participants  
[units: participants]
 		  109  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     109  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  43.4  ± 9.4  
Gender  
[units: participants]
 		 
Female     0  
Male     109  
Region of Enrollment  
[units: participants]
 		 
United States     109  



  Outcome Measures
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1.  Primary:   Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine   [ Time Frame: All study visits ]
  Show Outcome Measure 1

2.  Primary:   Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline   [ Time Frame: Week 28 ]
  Show Outcome Measure 2

3.  Primary:   Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline   [ Time Frame: Week 28 ]
  Show Outcome Measure 3

4.  Primary:   Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline   [ Time Frame: Week 28 ]
  Show Outcome Measure 4

5.  Primary:   Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline   [ Time Frame: Week 28 ]
  Show Outcome Measure 5

6.  Secondary:   Longitudinal Changes in CD4+ Cell Count From Baseline   [ Time Frame: Week 0, 4, 12, 28 ]
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7.  Secondary:   Longitudinal Changes in Plasma HIV-1 RNA From Baseline   [ Time Frame: Week 0, 4, 12, 28 ]
  Show Outcome Measure 7

8.  Secondary:   HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status   [ Time Frame: weeks 0, 28, and 76 ]
  Show Outcome Measure 8

9.  Secondary:   HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status   [ Time Frame: weeks 0, 28, and 76 ]
  Show Outcome Measure 9

10.  Secondary:   HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status   [ Time Frame: weeks 0, 28, and 76 ]
  Show Outcome Measure 10

11.  Secondary:   HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status   [ Time Frame: weeks 0, 28, and 76 ]
  Show Outcome Measure 11

12.  Secondary:   Type-specific Serum IgA Levels   [ Time Frame: weeks 0, 4, 12, 28, 52, and 72 ]
Results not yet posted.   Anticipated Posting Date:   12/2011   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Group Statistician
Organization: AMC
phone: 501-526-6712
e-mail: jylee@uams.edu


No publications provided by AIDS Malignancy Clinical Trials Consortium

Publications automatically indexed to this study:


Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00513526     History of Changes
Other Study ID Numbers: CDR0000559149, AMC-052, U01CA121947
Study First Received: August 6, 2007
Results First Received: June 28, 2011
Last Updated: November 2, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board