Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response (CORAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00772590
First received: October 14, 2008
Last updated: July 23, 2012
Last verified: July 2012
Results First Received: May 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: Hyper-immune Bovine Colostrum
Other: raltegravir placebo
Other: Hyper-immune Bovine Colostrum placebo
Drug: raltegravir and hyper-immune bovine colostrum

  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
100 patients were screening at 20 clinical sites in Australia

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 of 100 patients screened did not meet study inclusion criteria and were excluded from study

Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo

Participant Flow:   Overall Study
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo  
STARTED     19     19     18     17  
COMPLETED     19     19     18     17  
NOT COMPLETED     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo
Total Total of all reporting groups

Baseline Measures
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo     Total  
Number of Participants  
[units: participants]
  19     19     18     17     73  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     18     18     17     16     69  
>=65 years     1     1     1     1     4  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 11     56  ± 9     50  ± 10     55  ± 10     53  ± 10  
Gender  
[units: participants]
         
Female     2     1     0     1     4  
Male     17     18     18     16     69  
Region of Enrollment  
[units: participants]
         
Australia     19     19     18     17     73  



  Outcome Measures

1.  Primary:   Mean Change From Baseline CD4+ Cell Count   [ Time Frame: 24 weeks ]
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Measure Type Primary
Measure Title Mean Change From Baseline CD4+ Cell Count
Measure Description Comparison of normalised mean change from baseline CD4+ cell count
Time Frame 24 weeks  
Safety Issue No  

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.
intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.

Reporting Groups
  Description
Raltegravir + Hyper-immune Bovine Colostrum Raltegravir and hyper-immune bovine colostrum
Hyper-immune Bovine Colostrum Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir Raltegravir and Hyper-immune Bovine Colostrum placebo
Placebo Raltegravir placebo and hyper-immune bovine colostrum placebo

Measured Values
    Raltegravir + Hyper-immune Bovine Colostrum     Hyper-immune Bovine Colostrum     Raltegravir     Placebo  
Number of Participants Analyzed  
[units: participants]
  19     19     18     17  
Mean Change From Baseline CD4+ Cell Count  
[units: Cells/microlitre]
Mean ± Standard Deviation
  8.62  ± 32.19     2.68  ± 35.8     8.68  ± 44.58     21.87  ± 34.8  


Statistical Analysis 1 for Mean Change From Baseline CD4+ Cell Count
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Effect of interventions only measured in peripheral blood  


Results Point of Contact:  
Name/Title: Sean Emery
Organization: Kirby Institute, University of New South Wales
phone: +612 938509900
e-mail: semery@kirby.unsw.edu.au


Publications of Results:

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00772590     History of Changes
Other Study ID Numbers: NCHECR-CORAL 1
Study First Received: October 14, 2008
Results First Received: May 6, 2012
Last Updated: July 23, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration