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

Phase 4

Completed

Interventions: Drug: raltegravir and hyper-immune bovine colostrum
Drug: Hyper-immune Bovine Colostrum
Other: raltegravir placebo
Drug: Raltegravir
Other: Hyper-immune Bovine Colostrum placebo

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Raltegravir, bovine colostrum	raltegravir and hyper-immune bovine colostrum	Raltegravir and hyper-immune bovine colostrum
Hyper-immune bovine colostrum	Hyper-immune Bovine Colostrum	Hyper-immune bovine colostrum and Raltegravir placebo
Placebo	raltegravir placebo	Raltegravir placebo and hyper-immune bovine colostrum placebo
Placebo	Hyper-immune Bovine Colostrum placebo	Raltegravir placebo and hyper-immune bovine colostrum placebo
Raltegravir	Raltegravir	Raltegravir and Hyper-immune Bovine Colostrum Placebo