Efficacy in the central nervous system (CNS) of two combination regimens with different penetration rank in HIV-positive na?ve patients - SNC

Phase 1

• Conditions: HIV infection; MedDRA version: 9.1Level: LLTClassification code 10049072

• Registration Number: EUCTR2010-023264-40-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-23
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified