Clinical trial NCT00772590: Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
antiretroviral therapy intensification
suboptimal CD4+ T cell response
virological suppression
bovine colostrum
raltegravir
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2008-10-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mean Change From Baseline CD4+ Cell Count
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
name: Sean Emery, BSc (Hons), PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.