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A pilot, randomized trial to evaluate the lipid profile after antiretroviral regimens including nevirapine or atazanavir boosted with ritonavir in HIV-positive patients naive for antiretrovirals - STAR2

A pilot, randomized trial to evaluate the lipid profile after antiretroviral regimens including nevirapine or atazanavir boosted with ritonavir in HIV-positive patients naive for antiretrovirals - STAR2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007882-19-IT
Enrollment
Unknown
Registered
2007-12-21
Start date
2006-10-09
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

immunodefic syndrome - patients naive antiretroviral therapy MedDRA version: 9.1 Level: LLT Classification code 10000565 Term: Acquired immunodeficiency syndrome

Interventions

Trade Name: REYATAZ*60CPS 150MG Pharmaceutical Form: Tablet INN or Proposed INN: Atazanavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Trade Name: NORVIR

Sponsors

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -HIV infected subjects aged 18 years or older -creatinine Clearance>80 ml/min -art- naive -platelet count >50000/mmc -total neutrophils >750 cell/mmc -hemoglobin >10g/dlupper normal value -bilirubin total =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -women with CD4 >250 cell/mmc -menCD4 >400 cell/mm - pregnant womaen or women who are breastfeeding -alcohol or drag abuse or any condition which might compromise the aderence of the patients to the treatment -Proteinuria >300 mg/24 ore -liver cirrhosis -prior treatment with citotoxics chemiotherapeutic agents and any agents which can induce kidney damage

Design outcomes

Primary

MeasureTime frame
Main Objective: This study aimes at comparing the lipid profile after initiating atazanavir/ritonavir versus nevirapine containing regimens.;Secondary Objective: -To compare intracellular and plasma tenofovir concentrations when associated with atazanavir/ritonavir versus nevirapine -To assess whether different tenofovir concentrations may impact on toxicity profile (e.g., nephopathy) differently in the two study arms -To compare viro-immunological effectiveness of the two treatment arms (tenofovir/emtricitabine+nevirapine vs. tenofovir/emtricitabine+atazanavir/ritonavir);Primary end point(s): -ipercolesterolemia (HDL/ LDL) IPERTRIGLICERINEMIA—

Countries

Italy

Outcome results

None listed

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