Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir; Hyper-immune Bovine Colostrum; raltegravir placebo; Hyper-immune Bovine Colostrum placebo; raltegravir and hyper-immune bovine colostrum
Intervention description: Tablets, 400mg, twice daily; Tablet, 1800mg, twice daily; One tablet, twice daily; Three tablets twice daily; 400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; antiretroviral therapy intensification; suboptimal CD4+ T cell response; virological suppression; bovine colostrum; raltegravir

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.
    

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