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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.
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00772590
First received: October 14, 2008
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Mean Change From Baseline CD4+ Cell Count [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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
Other Name: Hyper-immune Bovine Colostrum
Experimental: Raltegravir
Raltegravir and Hyper-immune Bovine Colostrum Placebo
 Drug: Raltegravir
Tablets, 400mg, twice daily
Other Name: raltegravir
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
Other Name: Hyper-immune Bovine Colostrum placebo

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772590

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

Publications:

Responsible Party: Kirby Institute
ClinicalTrials.gov 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
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013