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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772590
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 24, 2012
Last Update Posted : August 24, 2012
Information provided by (Responsible Party):
Kirby Institute

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.

Condition or disease Intervention/treatment 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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (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
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Kirby Institute Identifier: NCT00772590     History of Changes
Other Study ID Numbers: NCHECR-CORAL 1
First Posted: October 15, 2008    Key Record Dates
Results First Posted: August 24, 2012
Last Update Posted: August 24, 2012
Last Verified: July 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