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Trial registered on ANZCTR


Registration number
ACTRN12609000575235
Ethics application status
Approved
Date submitted
24/02/2009
Date registered
14/07/2009
Date last updated
11/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological response
Scientific 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, Human Immunodeficiency Virus-1 (HIV-1) infected individuals with suboptimal CD4+ T cell responses despite prolonged virologic suppression
Secondary ID [1] 843 0
ClinicalTrials.gov ID number NCT00772590
Universal Trial Number (UTN)
Trial acronym
CORAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV)Infection 4376 0
Condition category
Condition code
Infection 4621 4621 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensification of antiretroviral therapy with oral raltegravir and or oral hyper-immune bovine colostrum 48 weeks.
Particiapants be be randomly allocated to one of four arms of the study
I. Raltegravir 400mg (1 tablet) twice daily + hyper-immune bovine colostrum placebo (3 tablets) twice daily
II. Raltegravir placebo (1 tablet) twice daily + hyper-immune bovine colostrum 1800mg (3 tablets) twice daily
III. Raltegravir 400mg (1 tablet) twice daily + hyper-immune bovine colostrum 1800mg (3 tablets) twice daily
IV. Raltegravir placebo (1 tablet) twice daily + hyper-immune bovine colostrum placebo (3 tablets) twice daily
Intervention code [1] 4108 0
Treatment: Drugs
Comparator / control treatment
raltegravir placebo is made to match the 400mg raltegravir image and is made of lactose monhydrate, cellulose- microcrystalline, Magnesium stearate (non bovine), Purified water (removed during processing) and Opadry II Pink (85F94224)

Hyper-immune bovine colostrum placebo is made to match the 600mg hyper-immune bovine colostrum image. It is made of
Milk Protein Concentrate .
Control group
Placebo

Outcomes
Primary outcome [1] 5493 0
Change from baseline of CD4+ T cell count of comparisons 1) raltegravir versus placebo and 2) hyper-immune bovine colostrum versus placebo as measured in peripheral blood
Timepoint [1] 5493 0
Primary assessment will be done at 24 weeks from baseline
Secondary outcome [1] 9255 0
Change in T cell count, T cell percentage, activated T cells, microbial translocation markers, plasma HIV Ribonucleic Acid (RNA) - with limit of detection of 0.4 HIV RNA copies/mL, immune activation markers and proportion of patients with CD4+ T cells greater than 350 cells/microlitre over 48 weeks
Timepoint [1] 9255 0
24 weeks and 48 weeks from baseline

Eligibility
Key inclusion criteria
1. Documented HIV-1 infection
2. Age >18 years
3. Signed informed consent
4. Receiving combination ART for at least 12 months with a stable cART regimen for a minimum of 6 months.
5. Two consecutive plasma HIV RNA viral load measurements <50 in the 9 months preceding the screening visit.
6. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receiving a cART regimen containing an integrase inhibitor
2. Anticipated change of cART in the 24 weeks following randomisation
3. Participating in study with an investigational compound or device within 30 days of signing informed consent
4. Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
5. Pregnant or breastfeeding woman
6. Cow’s milk allergy
7. Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
8. A known cause of impaired CD4+ T cell gain: for example individuals whose current cART regimen contains both tenofovir and didanosine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1594 0
2010
Recruitment postcode(s) [2] 1599 0
2031
Recruitment postcode(s) [3] 1600 0
2050
Recruitment postcode(s) [4] 1596 0
2065
Recruitment postcode(s) [5] 1595 0
2134
Recruitment postcode(s) [6] 1598 0
2170
Recruitment postcode(s) [7] 1597 0
2480
Recruitment postcode(s) [8] 1603 0
3004
Recruitment postcode(s) [9] 1601 0
3053
Recruitment postcode(s) [10] 1602 0
3141
Recruitment postcode(s) [11] 1604 0
4001
Recruitment postcode(s) [12] 1605 0
4101
Recruitment postcode(s) [13] 1606 0
4220
Recruitment postcode(s) [14] 1607 0
4560
Recruitment postcode(s) [15] 1609 0
6000
Recruitment postcode(s) [16] 1608 0
6160

Funding & Sponsors
Funding source category [1] 4809 0
University
Name [1] 4809 0
National Centre in HIV Epidemiology and Clinical Research University of New South Wales (UNSW)
Country [1] 4809 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
Kensington
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 4107 0
None
Name [1] 4107 0
Address [1] 4107 0
Country [1] 4107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6601 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 6601 0
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 6601 0
Australia
Date submitted for ethics approval [1] 6601 0
Approval date [1] 6601 0
16/10/2008
Ethics approval number [1] 6601 0
08/SVH/150

Summary
Brief summary
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 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29318 0
Address 29318 0
Country 29318 0
Phone 29318 0
Fax 29318 0
Email 29318 0
Contact person for public queries
Name 12565 0
Professor Sean Emery
Address 12565 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level2
376 Victoria Street
Darlinghurst NSW 2010
Country 12565 0
Australia
Phone 12565 0
(+61 2) 9385 0900
Fax 12565 0
(+61 2) 9385 0910
Email 12565 0
semery@nchecr.unsw.edu.au
Contact person for scientific queries
Name 3493 0
Dr Helen Byakwaga
Address 3493 0
National Centre in HIV Epidemiology and Clinical Research (NCHECR)
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 3493 0
Australia
Phone 3493 0
(+61 2) 9385 0900
Fax 3493 0
(+61 2) 9385 0910
Email 3493 0
hbyakwaga@nchecr.unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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