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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00772590
Acronym
CORAL
Enrollment
75
Registered
2008-10-15
Start date
2009-03-31
Completion date
2011-06-30
Last updated
2012-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

Brief 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.

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

Interventions

DRUGRaltegravir

Tablets, 400mg, twice daily

DRUGHyper-immune Bovine Colostrum

Tablet, 1800mg, twice daily

OTHERraltegravir placebo

One tablet, twice daily

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

Sponsors

Kirby Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean Change From Baseline CD4+ Cell Count24 weeksComparison of normalised mean change from baseline CD4+ cell count

Participant flow

Recruitment details

100 patients were screening at 20 clinical sites in Australia

Pre-assignment details

25 of 100 patients screened did not meet study inclusion criteria and were excluded from study

Participants by arm

ArmCount
Raltegravir + Hyper-immune Bovine Colostrum
Raltegravir and hyper-immune bovine colostrum
19
Hyper-immune Bovine Colostrum
Hyper-immune bovine colostrum and Raltegravir placebo
19
Raltegravir
Raltegravir and Hyper-immune Bovine Colostrum placebo
18
Placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
17
Total73

Baseline characteristics

CharacteristicHyper-immune Bovine ColostrumRaltegravirRaltegravir + Hyper-immune Bovine ColostrumPlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants1 Participants1 Participants4 Participants
Age, Categorical
Between 18 and 65 years
18 Participants17 Participants18 Participants16 Participants69 Participants
Age Continuous56 years
STANDARD_DEVIATION 9
50 years
STANDARD_DEVIATION 10
52 years
STANDARD_DEVIATION 11
55 years
STANDARD_DEVIATION 10
53 years
STANDARD_DEVIATION 10
Region of Enrollment
Australia
19 participants18 participants19 participants17 participants73 participants
Sex: Female, Male
Female
1 Participants0 Participants2 Participants1 Participants4 Participants
Sex: Female, Male
Male
18 Participants18 Participants17 Participants16 Participants69 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 190 / 190 / 180 / 17
serious
Total, serious adverse events
1 / 190 / 191 / 181 / 17

Outcome results

Primary

Mean Change From Baseline CD4+ Cell Count

Comparison of normalised mean change from baseline CD4+ cell count

Time frame: 24 weeks

Population: intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.

ArmMeasureValue (MEAN)Dispersion
Raltegravir + Hyper-immune Bovine ColostrumMean Change From Baseline CD4+ Cell Count8.62 Cells/microlitreStandard Deviation 32.19
Hyper-immune Bovine ColostrumMean Change From Baseline CD4+ Cell Count2.68 Cells/microlitreStandard Deviation 35.8
RaltegravirMean Change From Baseline CD4+ Cell Count8.68 Cells/microlitreStandard Deviation 44.58
PlaceboMean Change From Baseline CD4+ Cell Count21.87 Cells/microlitreStandard Deviation 34.8
p-value: <0.01ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026