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

October 14, 2008
July 23, 2012
March 2009
March 2010   (final data collection date for primary outcome measure)
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
The primary endpoint will be time-weighted change from baseline of CD4+ T cell count at week 24. Primary comparisons will compare 1) raltegravir versus placebo and 2) hyper-immune bovine colostrum versus placebo. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00772590 on ClinicalTrials.gov Archive Site
Not Provided
Change in CD4+ T cell percentage, microbial translocation markers, activated T cells, plasma HIV RNA (with limit of detection of 0.4 HIV RNA copies/mL), immune activation markers and proportion of patients with CD4+ T cells >350 cells/µL over 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
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

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Raltegravir
    Tablets, 400mg, twice daily
    Other Name: raltegravir
  • Drug: Hyper-immune Bovine Colostrum
    Tablet, 1800mg, twice daily
    Other Name: Hyper-immune Bovine Colostrum
  • 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
  • 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: Raltegravir, bovine colostrum
    Raltegravir and hyper-immune bovine colostrum
    Intervention: Drug: raltegravir and hyper-immune bovine colostrum
  • Experimental: Hyper-immune bovine colostrum
    Hyper-immune bovine colostrum and Raltegravir placebo
    Intervention: Drug: Hyper-immune Bovine Colostrum
  • Experimental: Raltegravir
    Raltegravir and Hyper-immune Bovine Colostrum Placebo
    Intervention: Drug: Raltegravir
  • Placebo Comparator: Placebo
    Raltegravir placebo and hyper-immune bovine colostrum placebo
    Interventions:
    • Other: raltegravir placebo
    • Other: Hyper-immune Bovine Colostrum placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00772590
NCHECR-CORAL 1
No
Kirby Institute
Kirby Institute
Not Provided
Principal Investigator: Sean Emery, BSc (Hons), PhD National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Kirby Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP