Status:
COMPLETED
A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders. We also are ...
Detailed Description
To our knowledge our study is the first study showing persistent apoptosis in a subgroup of patients with complete viral suppression in association with poor immune recovery. Immune alterations indepe...
Eligibility Criteria
Inclusion
- HIV Infection documented CD4+ count within the last 30 days (or drawn with screening labs)
- Currently on a stable 3-drug HAART regimen including 2 NRTIs for \> 6 month viral load (VL) \< 50/mm3 for \> 6 months, last within the last 30 days (or drawn with screening labs)
- Partial immune responder or immune non-responder
- Age \> 18 years
- Labs (drawn at screening)
- Alanine transaminase (ALT) \< 5 X the upper limit of normal (ULN)
- Total bili \< 2 X ULN
- Creatinine \< 2.0 mg/dL
Exclusion
- Prior therapy with Kaletra
- Known hypersensitivity to Ritonavir
- Therapy the drugs with potential serious drug interactions: flecainide, propafenone, astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, lovastatin, simvastatin, midazolam, triazolam, and St. John's wart.
- Pregnancy; breast feeding
- Current malignancy requiring CT
- Use of systemic corticosteroids, immunosuppressive, or cytotoxic agents within the last 45 days
- Fever and/or evidence of an active infectious complication
- Currently in another interventional clinical trial
- Receiving Interleukin-2 (IL-2) or any other cytokine or growth factor
- Enrollment in another interventional clinical trial
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00145795
Start Date
April 1 2004
End Date
December 1 2009
Last Update
June 15 2022
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60607