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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023264-40-IT

Enrollment

Registered

2010-12-23

Start date

2010-10-21

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection MedDRA version: 9.1 Level: LLT Classification code 10049072

Interventions

Trade Name: KALETRA Pharmaceutical Form: Tablet INN or Proposed INN: LOPINAVIR CAS Number: 192725-17-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- INN or P

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 2% Karnofsky index < 50

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate virological efficacy of antiretroviral therapy in the CNS;Secondary Objective: - To evaluate the improvement of HIV-associated Neurocognitive Disorders - To evaluate HIV-RNA suppression in plasma - To evaluate CD4+ T cells increase in plasma - To determine variation in intrathecal immunoactivation status by measurement of CSF neopterin, cytokine, chemokine and adhesins concentration and frequency of activated lymphomonocytes - To determine variation in axonal injury by measurement of CSF light chain neurofilament;Primary end point(s): Evaluation of the proportion of patients with CSF viral load suppression (HIV-RNA < 50 copies/ml) after 24 weeks	—

Measure

Time frame

Main Objective: To evaluate virological efficacy of antiretroviral therapy in the CNS;Secondary Objective: - To evaluate the improvement of HIV-associated Neurocognitive Disorders - To evaluate HIV-RNA suppression in plasma - To evaluate CD4+ T cells increase in plasma - To determine variation in intrathecal immunoactivation status by measurement of CSF neopterin, cytokine, chemokine and adhesins concentration and frequency of activated lymphomonocytes - To determine variation in axonal injury by measurement of CSF light chain neurofilament;Primary end point(s): Evaluation of the proportion of patients with CSF viral load suppression (HIV-RNA < 50 copies/ml) after 24 weeks

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026