Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
CORAL
Randomised Double-blind Placebo Controlled Study to Measure the Effect of Antiretroviral Therapy (ART) Intensification With Raltegravir and/or Hyper-immune Bovine Colostrum on CD4+ T Cell Count in ART Treated, HIV-1 Infected Individuals With Suboptimal CD4+ T Cell Responses
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Mar 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 24, 2012
CompletedAugust 24, 2012
July 1, 2012
1 year
October 14, 2008
May 6, 2012
July 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline CD4+ Cell Count
Comparison of normalised mean change from baseline CD4+ cell count
24 weeks
Study Arms (4)
Raltegravir, bovine colostrum
EXPERIMENTALRaltegravir and hyper-immune bovine colostrum
Hyper-immune bovine colostrum
EXPERIMENTALHyper-immune bovine colostrum and Raltegravir placebo
Raltegravir
EXPERIMENTALRaltegravir and Hyper-immune Bovine Colostrum Placebo
Placebo
PLACEBO COMPARATORRaltegravir placebo and hyper-immune bovine colostrum placebo
Interventions
400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
Eligibility Criteria
You may qualify if:
- Documented HIV-1 infection
- Age \>18 years
- Signed informed consent
- Receiving combination ART (cART) for at least 12 months with a stable cART regimen for a minimum of 6 months. A formulation change or modification of dosage schedule is acceptable (for example ritonavir - boosted lopinavir capsules for tablets, abacavir (ABC) or tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC) as single agents for ABC/3TC or TDF/FTC fixed dose combinations)
- Two consecutive plasma HIV RNA viral load measurements \<50 (or \<400 copies/mL depending upon lowest level of detection of the local assay) in the 9 months preceding the screening visit. A single isolated HIV RNA viral load \>50 (or \>400) copies/mL will not exclude the patient provided the viral load result \>50 (or 400) copies/mL on therapy follows a previous result \<50 (or 400) copies/mL, and there is a follow-up result \<50 copies/mL at least one week following the \>50 (or 400) copies/mL reading in the absence of a change to any component of the ART regimen.
- CD4+ T cell count \<350 cells/µL throughout the 6 months preceding the screening visit with \<50 cells/µL increase in the last 12 months
You may not qualify if:
- Receiving a cART regimen containing an integrase inhibitor
- Anticipated change of cART in the 24 weeks following randomisation
- Participating in study with an investigational compound or device within 30 days of signing informed consent
- Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
- Pregnant or breastfeeding woman
- Cow's milk allergy
- Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
- A known cause of impaired CD4+ T cell gain: for example, patients with splenomegaly or individuals whose current cART regimen contains both tenofovir and didanosine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Related Publications (1)
Byakwaga H, Kelly M, Purcell DF, French MA, Amin J, Lewin SR, Haskelberg H, Kelleher AD, Garsia R, Boyd MA, Cooper DA, Emery S; CORAL Study Group. Intensification of antiretroviral therapy with raltegravir or addition of hyperimmune bovine colostrum in HIV-infected patients with suboptimal CD4+ T-cell response: a randomized controlled trial. J Infect Dis. 2011 Nov 15;204(10):1532-40. doi: 10.1093/infdis/jir559. Epub 2011 Sep 19.
PMID: 21930607RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Effect of interventions only measured in peripheral blood
Results Point of Contact
- Title
- Sean Emery
- Organization
- Kirby Institute, University of New South Wales
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Emery, BSc (Hons), PhD
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
June 1, 2011
Last Updated
August 24, 2012
Results First Posted
August 24, 2012
Record last verified: 2012-07