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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Hyper-immune Bovine Colostrum
* Other: raltegravir placebo
* Other: Hyper-immune Bovine Colostrum placebo
* Drug: raltegravir and hyper-immune bovine colostrum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir, bovine colostrum<br>Raltegravir and hyper-immune bovine colostrum | Drug: raltegravir and hyper-immune bovine colostrum<br>* 400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum<br>* Other names: Raltegravir + hyper-immune bovine colostrum;|
| Experimental: Hyper-immune bovine colostrum<br>Hyper-immune bovine colostrum and Raltegravir placebo | Drug: Hyper-immune Bovine Colostrum<br>* Tablet, 1800mg, twice daily<br>|
| Experimental: Raltegravir<br>Raltegravir and Hyper-immune Bovine Colostrum Placebo | Drug: Raltegravir<br>* Tablets, 400mg, twice daily<br>|
| Placebo Comparator: Placebo<br>Raltegravir placebo and hyper-immune bovine colostrum placebo | Other: raltegravir placebo<br>* One tablet, twice daily<br>* Other names: placebo;Other: Hyper-immune Bovine Colostrum placebo<br>* Three tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline CD4+ Cell Count | Comparison of normalised mean change from baseline CD4+ cell count | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, antiretroviral therapy intensification, suboptimal CD4+ T cell response, virological suppression, bovine colostrum, raltegravir