Status:
COMPLETED
CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes
Lead Sponsor:
University of Cologne
Conditions:
Acquired Immunodeficiency Syndrome
HIV Infections
Eligibility:
All Genders
20-60 years
Phase:
PHASE3
Brief Summary
Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2 nucleoside reverse transcrip...
Eligibility Criteria
Inclusion
- Recent, non-acute HIV-1 infection
- Caucasians
- BMI between 17.5 and 30 kg/m2
- CD4 count \<200 cells/µl
- Plasma viral load \>100,000 HIV-1 RNA copies/ml
Exclusion
- Actual or previous antiretroviral therapy
- Acute illness
- Coinfection with HBV or HCV
- Opportunistic infection (Pneumocystis jiroveci pneumonia, Toxoplasma gondii encephalitis, Mycobacterium ssp. infection, syphilis, cryptosporidiosis, cryptococcosis, aspergillosis, cytomegalovirus infection or progressive multifocal leukoencephalopathy)
- Hepatic or renal disorder
- Severe cardiovascular disease
- Hematologic disorder
- Autoimmune disorder
- Diabetes mellitus or other severe endocrine disorder
- Malignancy
- Neurocognitive disorder
- Psychiatric disorder
- Drug or alcohol addiction
- Chronic drug use (except of blood pressure-lowering or lipid-lowering drugs or proton-pump inhibitors)
- Any acute medication within 7 days or vaccination within 30 days prior to entry
- Pregnancy or lactation
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00966160
Start Date
January 1 1999
End Date
December 1 2008
Last Update
September 29 2009
Active Locations (1)
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1
Medical Clinic I and Department of Pharmacology, University of Cologne
Cologne, Germany