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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)

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ClinicalTrials.gov Identifier: NCT00772590
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 24, 2012
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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
Enrollment 75
Recruitment Details 100 patients were screening at 20 clinical sites in Australia
Pre-assignment Details 25 of 100 patients screened did not meet study inclusion criteria and were excluded from study
Arm/Group Title Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Hide Arm/Group Description Raltegravir and hyper-immune bovine colostrum Hyper-immune bovine colostrum and Raltegravir placebo Raltegravir and Hyper-immune Bovine Colostrum placebo Raltegravir placebo and hyper-immune bovine colostrum placebo
Period Title: Overall Study
Started 19 19 18 17
Completed 19 19 18 17
Not Completed 0 0 0 0
Arm/Group Title Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo Total
Hide Arm/Group Description Raltegravir and hyper-immune bovine colostrum Hyper-immune bovine colostrum and Raltegravir placebo Raltegravir and Hyper-immune Bovine Colostrum placebo Raltegravir placebo and hyper-immune bovine colostrum placebo Total of all reporting groups
Overall Number of Baseline Participants 19 19 18 17 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 18 participants 17 participants 73 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  94.7%
18
  94.7%
17
  94.4%
16
  94.1%
69
  94.5%
>=65 years
1
   5.3%
1
   5.3%
1
   5.6%
1
   5.9%
4
   5.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 18 participants 17 participants 73 participants
52  (11) 56  (9) 50  (10) 55  (10) 53  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 18 participants 17 participants 73 participants
Female
2
  10.5%
1
   5.3%
0
   0.0%
1
   5.9%
4
   5.5%
Male
17
  89.5%
18
  94.7%
18
 100.0%
16
  94.1%
69
  94.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 19 participants 19 participants 18 participants 17 participants 73 participants
19 19 18 17 73
1.Primary Outcome
Title Mean Change From Baseline CD4+ Cell Count
Hide Description Comparison of normalised mean change from baseline CD4+ cell count
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.
Arm/Group Title Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Hide Arm/Group Description:
Raltegravir and hyper-immune bovine colostrum
Hyper-immune bovine colostrum and Raltegravir placebo
Raltegravir and Hyper-immune Bovine Colostrum placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
Overall Number of Participants Analyzed 19 19 18 17
Mean (Standard Deviation)
Unit of Measure: Cells/microlitre
8.62  (32.19) 2.68  (35.8) 8.68  (44.58) 21.87  (34.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir + Hyper-immune Bovine Colostrum, Hyper-immune Bovine Colostrum, Raltegravir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Baseline to week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Hide Arm/Group Description Raltegravir and hyper-immune bovine colostrum Hyper-immune bovine colostrum and Raltegravir placebo Raltegravir and Hyper-immune Bovine Colostrum placebo Raltegravir placebo and hyper-immune bovine colostrum placebo
All-Cause Mortality
Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   0/19 (0.00%)   1/18 (5.56%)   1/17 (5.88%) 
Cardiac disorders         
Hosp. for chest pain  1  1/19 (5.26%)  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Hosp. for possible Influenza A  1  0/19 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders         
Hosp. For cellulitis  1  0/19 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir + Hyper-immune Bovine Colostrum Hyper-immune Bovine Colostrum Raltegravir Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
Effect of interventions only measured in peripheral blood
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
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT00772590     History of Changes
Other Study ID Numbers: NCHECR-CORAL 1
First Submitted: October 14, 2008
First Posted: October 15, 2008
Results First Submitted: May 6, 2012
Results First Posted: August 24, 2012
Last Update Posted: August 24, 2012