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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
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.

Condition Intervention Phase
HIV Infections
Drug: Raltegravir
Drug: Hyper-immune Bovine Colostrum
Other: raltegravir placebo
Other: Hyper-immune Bovine Colostrum placebo
Drug: raltegravir and hyper-immune bovine colostrum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Mean Change From Baseline CD4+ Cell Count [ Time Frame: 24 weeks ]
    Comparison of normalised mean change from baseline CD4+ cell count

Enrollment: 75
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir, bovine colostrum
Raltegravir and hyper-immune bovine colostrum
Drug: raltegravir and hyper-immune bovine colostrum
400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
Other Name: Raltegravir + hyper-immune bovine colostrum
Experimental: Hyper-immune bovine colostrum
Hyper-immune bovine colostrum and Raltegravir placebo
Drug: Hyper-immune Bovine Colostrum
Tablet, 1800mg, twice daily
Experimental: Raltegravir
Raltegravir and Hyper-immune Bovine Colostrum Placebo
Drug: Raltegravir
Tablets, 400mg, twice daily
Placebo Comparator: Placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
Other: raltegravir placebo
One tablet, twice daily
Other Name: placebo
Other: Hyper-immune Bovine Colostrum placebo
Three tablets twice daily

Detailed Description:

The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.

Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00772590

Sponsors and Collaborators
Kirby Institute
Principal Investigator: Sean Emery, BSc (Hons), PhD National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
  More Information

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

Keywords provided by Kirby Institute:
antiretroviral therapy intensification
suboptimal CD4+ T cell response
virological suppression
bovine colostrum

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017