Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

NCT ID: NCT00772590

Last Updated: 2012-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-06-30

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

Conditions

HIV Infections

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Raltegravir, bovine colostrum

Raltegravir and hyper-immune bovine colostrum

Group Type: EXPERIMENTAL

raltegravir and hyper-immune bovine colostrum

Intervention Type: DRUG

400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum

Hyper-immune bovine colostrum

Hyper-immune bovine colostrum and Raltegravir placebo

Group Type: EXPERIMENTAL

Hyper-immune Bovine Colostrum

Intervention Type: DRUG

Tablet, 1800mg, twice daily

Raltegravir

Raltegravir and Hyper-immune Bovine Colostrum Placebo

Group Type: EXPERIMENTAL

Raltegravir

Intervention Type: DRUG

Tablets, 400mg, twice daily

Placebo

Raltegravir placebo and hyper-immune bovine colostrum placebo

Group Type: PLACEBO_COMPARATOR

raltegravir placebo

Intervention Type: OTHER

One tablet, twice daily

Hyper-immune Bovine Colostrum placebo

Intervention Type: OTHER

Three tablets twice daily

Interventions

Raltegravir

Tablets, 400mg, twice daily

Intervention Type: DRUG

Hyper-immune Bovine Colostrum

Tablet, 1800mg, twice daily

Intervention Type: DRUG

raltegravir placebo

One tablet, twice daily

Intervention Type: OTHER

Hyper-immune Bovine Colostrum placebo

Three tablets twice daily

Intervention Type: OTHER

raltegravir and hyper-immune bovine colostrum

400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum

Intervention Type: DRUG

Other Intervention Names

placebo; Raltegravir + hyper-immune bovine colostrum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Emery, BSc (Hons), PhD

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: RESULT

PMID: 21930607 (View on PubMed)

Other Identifiers

NCHECR-CORAL 1

Identifier Type: -

Identifier Source: org_study_id