EUCTR2010-023264-40-IT
Active, not recruiting
Phase 1
Efficacy in the central nervous system (CNS) of two combination regimens with different penetration rank in HIV-positive na?ve patients - SNC
AZIENDA OSPEDALIERA S. GERARDO DI MONZA0 sites32 target enrollmentDecember 23, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV infection
- Sponsor
- AZIENDA OSPEDALIERA S. GERARDO DI MONZA
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Men and women between 18\-60 years of age. \- HIV positivity tested with ELISA and confirmed by Western Blot \- CD4\+ cell count \< 150 cell/?l \- Na?ve to HAART \- presence of documented asymptomatic neurocognitive impairment by using a neuropsychological test battery \- No resistance according to a baseline HIV genotype \- Negative pregnancy test effected at least 14 days before the beginning of treatment. \- Contraceptive method for women in fertile age \- Signing of informed consent \- HLA\-B\*5701 test negative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Presence of actual opportunistic CNS disease \- presence of documented mild neurocognitive disorder or HIV\-associated dementia by using a neuropsychological test battery; \- Presence of CNS diseases other than HIV\-associated neurocognitive disorders \- Presence of intolerance or allergies to the treatment \- Abnormalities in kidney profile (serum creatinine and creatinine clearance) \- Active intra\-venous drug user, alcoholics and patients considered not collaborative \- Pregnant or in breast\-feeding patients \- Patients with the following laboratory parameters abnormalities: • AST,ALT \> 2,5 times upper to the normal value • serum creatinine \> 1,5 times upper to the normal value • PMN \< 1000/µL • Hb \< 10 g/dL • PLTS \< 75,000/ µL • reticulocytes \> 2% Karnofsky index \< 50
Outcomes
Primary Outcomes
Not specified
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