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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.
Information provided by (Responsible Party):
Kirby Institute Identifier:
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;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, 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

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 19   19   18   17   73 
[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 
[Units: Years]
Mean (Standard Deviation)
 52  (11)   56  (9)   50  (10)   55  (10)   53  (10) 
[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 ]

  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
Effect of interventions only measured in peripheral blood

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

Results Point of Contact:  
Name/Title: Sean Emery
Organization: Kirby Institute, University of New South Wales
phone: +612 938509900

Publications of Results:

Responsible Party: Kirby Institute 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