Status:
TERMINATED
Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
University of Chicago
University of Illinois at Chicago
Conditions:
Acquired Immune Deficiency Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regi...
Detailed Description
DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to efavirenz (EFV), in combinat...
Eligibility Criteria
Inclusion
- HIV-1 infection
- The absence of exclusionary resistance mutations on a genotypic resistance assay
- Antiretroviral (ARV) drug-naïve
- Screening HIV-1 RNA \>1000 copies/mL
- Screening CD4+ T-cell count \< 200 cells/ml
- Laboratory values obtained within 30 days prior to study entry.
- Absolute neutrophil count (ANC) \>500/mm3
- Hemoglobin \>8.0 g/dL
- Platelet count \>40,000/mm3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase \<5 x ULN
- Total bilirubin \<2.5 x ULN
- Calculated creatinine clearance ≥60 mL/min (by Cockcroft-Gault equation)
- For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
- Contraception requirements
- Men and women age \>18 years and \< 60 years.
- Ability and willingness of subject or legal guardian/representative to give written informed consent.
Exclusion
- Currently breast-feeding.
- Use of immunomodulators, vaccines, growth hormone, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
- Known allergy/sensitivity to study drugs, pneumococcal polysaccharide vaccine, tetanus-diphtheria vaccine
- Receipt of pneumococcal polysaccharide vaccine or tetanus-diphtheria vaccine in the past 5 years.
- Active drug or alcohol use or dependence
- Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.
- Requirement for any current medications that are prohibited with any study treatment.
- Evidence of any major resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry
- Current or anticipated imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness
- History of, or current bipolar disorder, major depression, schizophrenia or other psychotic disorders
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00775606
Start Date
October 1 2008
End Date
January 1 2011
Last Update
May 26 2023
Active Locations (4)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
3
Howard Brown Health Center
Chicago, Illinois, United States, 60613
4
University of Chicago Hospital
Chicago, Illinois, United States, 60637