Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00667563
First received: April 25, 2008
Last updated: August 27, 2014
Last verified: August 2014
Results First Received: January 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cervical Cancer
Nonneoplastic Condition
Precancerous Condition
Interventions: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Genetic: DNA analysis
Genetic: polymerase chain reaction
Other: cytology specimen collection procedure
Procedure: colposcopic biopsy

  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
No text entered.

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
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Participant Flow:   Overall Study
    Gardasil Vaccination  
STARTED     150  
COMPLETED     126  
NOT COMPLETED     24  
Protocol Violation                 24  



  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.
Enrolled in study

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Baseline Measures
    Gardasil Vaccination  
Number of Participants  
[units: participants]
  150  
Age  
[units: years]
Mean ± Standard Deviation
  30.8  ± 5.2  
Gender  
[units: participants]
 
Female     150  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0   [ Time Frame: 52 weeks from study entry ]

2.  Primary:   Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count   [ Time Frame: Screening/Week 0, Weeks 2, 10, 26, and 52. ]

3.  Primary:   Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28   [ Time Frame: Week 28 ]

4.  Primary:   Number of Patients With a Significant Increase in HIV Viral Load   [ Time Frame: Screening/week 0, weeks, 2, 10, 26 and 52 ]
  Hide Outcome Measure 4

Measure Type Primary
Measure Title Number of Patients With a Significant Increase in HIV Viral Load
Measure Description Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions
Time Frame Screening/week 0, weeks, 2, 10, 26 and 52  
Safety Issue Yes  

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.
No text entered.

Reporting Groups
  Description
Gardasil Vaccination

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.


Measured Values
    Gardasil Vaccination  
Number of Participants Analyzed  
[units: participants]
  150  
Number of Patients With a Significant Increase in HIV Viral Load  
[units: participants]
  7  

No statistical analysis provided for Number of Patients With a Significant Increase in HIV Viral Load



5.  Primary:   Number of Patients With Detectable Antibodies to HPV-6   [ Time Frame: 28 weeks ]

6.  Primary:   Number of Patients With Detectable Antibodies to HPV-11   [ Time Frame: 28 weeks ]

7.  Primary:   Number of Patients With Detectable Antibodies to HPV-18   [ Time Frame: 28 weeks ]


  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
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  More Information