CompletedNCT00772590CORALUpdated Aug 24, 2012Results posted

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 interventional study of Raltegravir and Hyper-immune Bovine Colostrum in HIV Infections, sponsored by Kirby Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-24.

Sponsored by Kirby Institute · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 75
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

HIV Infections

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HIV Infections 4,258

Keywords

HIV
antiretroviral therapy intensification
suboptimal CD4+ T cell response
virological suppression
bovine colostrum
raltegravir

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 75 is close to the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 75 participants (actual)

Study arms

Experimental
Raltegravir, bovine colostrum
Raltegravir and hyper-immune bovine colostrum
Drug: raltegravir and hyper-immune bovine colostrum
Experimental
Hyper-immune bovine colostrum
Hyper-immune bovine colostrum and Raltegravir placebo
Drug: Hyper-immune Bovine Colostrum
Experimental
Raltegravir
Raltegravir and Hyper-immune Bovine Colostrum Placebo
Drug: Raltegravir
Placebo comparator
Placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
Other: raltegravir placebo · Other: Hyper-immune Bovine Colostrum placebo

Interventions

DrugRaltegravir
Tablets, 400mg, twice daily
DrugHyper-immune Bovine Colostrum
Tablet, 1800mg, twice daily
Otherraltegravir placebo
One tablet, twice daily
Also known as: placebo
OtherHyper-immune Bovine Colostrum placebo
Three tablets twice daily
Drugraltegravir and hyper-immune bovine colostrum
400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
Also known as: Raltegravir + hyper-immune bovine colostrum

What researchers measure

Primary outcomes

Mean Change From Baseline CD4+ Cell Count
Comparison of normalised mean change from baseline CD4+ cell count
Time frame: 24 weeks

Results

Posted Aug 24, 2012

Limitations and caveats

Effect of interventions only measured in peripheral blood

Participant flow

100 patients were screening at 20 clinical sites in Australia

Participant flow — Overall Study
Milestone	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo
Started	19	19	18	17
Completed	19	19	18	17
Not completed	0	0	0	0

Outcome measures

PrimaryMean Change From Baseline CD4+ Cell Count

Comparison of normalised mean change from baseline CD4+ cell count

Time frame:: 24 weeks
Reported as:: Mean · Cells/microlitre

Mean Change From Baseline CD4+ Cell Count
Cells/microlitre	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo
Mean Change From Baseline CD4+ Cell Count	8.62 ± 32.19	2.68 ± 35.8	8.68 ± 44.58	21.87 ± 34.8

Statistical analysis

Raltegravir + Hyper-immune Bovine Colostrum vs Hyper-immune Bovine Colostrum vs Raltegravir vs Placebo · ANOVA · p = <0.01

Adverse events

Collected over Baseline to week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Raltegravir + Hyper-immune Bovine Colostrum	—	1/19 (5.3%)	0/19 (0%)
Hyper-immune Bovine Colostrum	—	0/19 (0%)	0/19 (0%)
Raltegravir	—	1/18 (5.6%)	0/18 (0%)
Placebo	—	1/17 (5.9%)	0/17 (0%)

Most frequent serious events

Most frequent serious events
Event	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo
Hosp. for possible Influenza ARespiratory, thoracic and mediastinal disorders	0/19	0/19	0/18	1/17
Hosp. For cellulitisSkin and subcutaneous tissue disorders	0/19	0/19	1/18	0/17
Hosp. for chest painCardiac disorders	1/19	0/19	0/18	0/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	18	18	17	16	69
>=65 years	1	1	1	1	4

Age Continuous
Age Continuous(years)	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo	Total
Mean	52 ± 11	56 ± 9	50 ± 10	55 ± 10	53 ± 10

Sex: Female, Male
Sex: Female, Male(Participants)	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo	Total
Female	2	1	0	1	4
Male	17	18	18	16	69

Region of Enrollment
Region of Enrollment(participants)	Raltegravir + Hyper-immune Bovine Colostrum	Hyper-immune Bovine Colostrum	Raltegravir	Placebo	Total
Australia	19	19	18	17	73

Study locations

No study locations are listed for this record.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00772590
Lead sponsor: Kirby Institute
Responsible party: Sponsor
First posted: Oct 15, 2008
Start date: Mar 2009
Primary completion: Mar 2010
Completion: Jun 2011
Results posted: Aug 24, 2012
Last update: Aug 24, 2012

Study contacts

Sean Emery, BSc (Hons), PhD

principal investigator · National Centre in HIV Epidemiology and Clinical Research, University of New South Wales

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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