Status:
COMPLETED
Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response
Lead Sponsor:
Kirby Institute
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 intensif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00772590
Start Date
March 1 2009
End Date
June 1 2011
Last Update
August 24 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.