Pilot study for the evaluation of the safety and the feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in patients on stable treatment with two NRTIs + atazanavir/ritonavir with optimal virologic response (AtLaS). - ND

• Conditions: HIV; MedDRA version: 9.1Level: LLTClassification code 10020443Term: Human immunodeficiency virus syndrome

• Registration Number: EUCTR2009-011273-32-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients treated with a stable regimen including 2NRTIs + ATV/r for at least 6 months
Aged 18 years or older
With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
With CD4 cell count >200 cells/ &#956;L for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
Who gave informed consent to the participation to the study
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or breast feeding, desire of pregnancy in the short term
Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues.
Previous major toxicity to any of the study drugs
Patients with insufficient atazanavir plasma concentration (lower than 0.23 &#956;g/mL at 12 &#61617;2 hours or 0.15 &#956;g/mL at 24 &#61617;2 hours post-dosing) at screening
Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid levels)
Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications (as per product information)
Detection of HBsAg in plasma

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1)To verify the safety of the study treatment, defined as the persistent control of the virus replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir;Secondary Objective: To collect relevant informations about the safety and the metabolic impact of this strategy.;Primary end point(s): proportion of patients with virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) within 48 weeks at intention-to.treat analysis