Status:
COMPLETED
Atazanavir and Lamivudine for Treatment Simplification
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objectives of the study: 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 wi...
Detailed Description
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and n...
Eligibility Criteria
Inclusion
- Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load \< 50 copies/mL in two consecutive determinations at least 3 months apart
- With CD4 cell count \> 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least
Exclusion
- 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 nucleosidic analogues
- Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
- Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
- Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00885482
Start Date
May 1 2009
End Date
May 1 2011
Last Update
March 13 2015
Active Locations (1)
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1
Catholic University of Sacred Heart
Rome, Italy, 00168