HIV InfectionsPhase 4CORALNCT00772590
Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
A Phase 4 study testing Raltegravir, Hyper-immune Bovine Colostrum and raltegravir and hyper-immune bovine colostrum in people with HIV Infections, run by Kirby Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir, Hyper-immune Bovine Colostrum and raltegravir and hyper-immune bovine colostrum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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
- Conditions
- HIV Infections
- Being tested
- Raltegravir, Hyper-immune Bovine Colostrum, raltegravir placebo, Hyper-immune Bovine Colostrum placebo, raltegravir and hyper-immune bovine colostrum
- Keywords
- HIV, antiretroviral therapy intensification, suboptimal CD4+ T cell response, virological suppression, bovine colostrum, raltegravir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Tablets, 400mg, twice daily
Hyper-immune Bovine ColostrumDrug
Tablet, 1800mg, twice daily
raltegravir placeboOther
Also called placebo
One tablet, twice daily
Hyper-immune Bovine Colostrum placeboOther
Three tablets twice daily
raltegravir and hyper-immune bovine colostrumDrug
Also called Raltegravir + hyper-immune bovine colostrum
400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir, bovine colostrum | Experimental | Raltegravir and hyper-immune bovine colostrum Receives: Drug: raltegravir and hyper-immune bovine colostrum |
| Hyper-immune bovine colostrum | Experimental | Hyper-immune bovine colostrum and Raltegravir placebo Receives: Drug: Hyper-immune Bovine Colostrum |
| Raltegravir | Experimental | Raltegravir and Hyper-immune Bovine Colostrum Placebo Receives: Drug: Raltegravir |
| Placebo | Placebo comparator | Raltegravir placebo and hyper-immune bovine colostrum placebo Receives: Other: raltegravir placebo; Other: Hyper-immune Bovine Colostrum placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline CD4+ Cell Count
Comparison of normalised mean change from baseline CD4+ cell count
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sean Emery, BSc (Hons), PhD, Principal investigator, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772590
- Sponsor's protocol ID
- NCHECR-CORAL 1
- Acronym
- CORAL
- Status last verified
- Jul 2012
- First submitted
- 14 Oct 2008
- Last updated
- 24 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21930607
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00772590
- Acronym / sponsor ID
- CORAL / NCHECR-CORAL 1
- Conditions
- HIV Infections
- Keywords
- HIV, antiretroviral therapy intensification, suboptimal CD4+ T cell response, virological suppression, bovine colostrum, raltegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 24 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Raltegravir, bovine colostrum | Experimental | Drug: raltegravir and hyper-immune bovine colostrumRaltegravir and hyper-immune bovine colostrum |
| Hyper-immune bovine colostrum | Experimental | Drug: Hyper-immune Bovine ColostrumHyper-immune bovine colostrum and Raltegravir placebo |
| Raltegravir | Experimental | Drug: RaltegravirRaltegravir and Hyper-immune Bovine Colostrum Placebo |
| Placebo | Placebo comparator | Other: raltegravir placebo, Other: Hyper-immune Bovine Colostrum placeboRaltegravir placebo and hyper-immune bovine colostrum placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirTablets, 400mg, twice daily | Drug | Raltegravir |
| Hyper-immune Bovine ColostrumTablet, 1800mg, twice daily | Drug | Hyper-immune bovine colostrum |
| raltegravir placeboAlso: placeboOne tablet, twice daily | Other | Placebo |
| Hyper-immune Bovine Colostrum placeboThree tablets twice daily | Other | Placebo |
| raltegravir and hyper-immune bovine colostrumAlso: Raltegravir + hyper-immune bovine colostrum400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum | Drug | Raltegravir, bovine colostrum |
Primary outcome
Mean Change From Baseline CD4+ Cell Count
Time frame: 24 weeks
Comparison of normalised mean change from baseline CD4+ cell count
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21930607Byakwaga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Emery, BSc (Hons), PhD principal investigator
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir, Hyper-immune Bovine Colostrum and raltegravir and hyper-immune bovine colostrum in people with HIV Infections, run by Kirby Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline CD4+ Cell Count (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.