EUCTR2009-011273-32-ITActive, not recruitingNot Applicable
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
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 sitesStarted: April 1, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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/ μL 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 μg/mL at 12 2 hours or 0.15 μg/mL at 24 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
Investigators
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