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Atazanavir and Lamivudine for Treatment Simplification (AtLaS)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lamiduvine (Epivir)
Atazanavir (Reyataz)
Ritonavir (Norvir)
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS, HAART, Simplification, Atazanavir, Lamivudine, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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 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

Sites / Locations

  • Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.

Outcomes

Primary Outcome Measures

Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis

Secondary Outcome Measures

Time to Virological Failure at Survival Analysis
Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis
Evolution of CD4 Cell Count During the 48 Weeks
Evolution of Adherence and Quality of Life During the 48 Weeks
Evolution of Atazanavir Plasma Concentrations During the 48 Weeks
Change of Metabolic Parameters at 48 Weeks
Change of the Results of Neurocognitive Tests at 48 Weeks
Change of Bone Density and of Subcutaneous Fat at 48 Weeks

Full Information

First Posted
April 20, 2009
Last Updated
February 23, 2015
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00885482
Brief Title
Atazanavir and Lamivudine for Treatment Simplification
Acronym
AtLaS
Official Title
Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives of the study: 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. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.
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 nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density. Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV/AIDS, HAART, Simplification, Atazanavir, Lamivudine, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Intervention Type
Drug
Intervention Name(s)
Lamiduvine (Epivir)
Intervention Description
Epivir 300 mg
Intervention Type
Drug
Intervention Name(s)
Atazanavir (Reyataz)
Intervention Description
Reyataz 300 mg
Intervention Type
Drug
Intervention Name(s)
Ritonavir (Norvir)
Intervention Description
Norvir 100 mg
Primary Outcome Measure Information:
Title
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Time to Virological Failure at Survival Analysis
Time Frame
48 weeks
Title
Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis
Time Frame
48 weeks
Title
Evolution of CD4 Cell Count During the 48 Weeks
Time Frame
48 weeks
Title
Evolution of Adherence and Quality of Life During the 48 Weeks
Time Frame
48 weeks
Title
Evolution of Atazanavir Plasma Concentrations During the 48 Weeks
Time Frame
48 weeks
Title
Change of Metabolic Parameters at 48 Weeks
Time Frame
48 weeks
Title
Change of the Results of Neurocognitive Tests at 48 Weeks
Time Frame
48 weeks
Title
Change of Bone Density and of Subcutaneous Fat at 48 Weeks
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea De Luca, MD
Organizational Affiliation
Catholic University of Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21329725
Citation
Fabbiani M, Bracciale L, Doino M, D'Avino A, Marzocchetti A, Navarra P, Cauda R, De Luca A, Di Giambenedetto S. Tenofovir discontinuation could predispose to urolithiasis in atazanavir-treated patients. J Infect. 2011 Apr;62(4):319-21. doi: 10.1016/j.jinf.2011.02.004. Epub 2011 Feb 15. No abstract available.
Results Reference
derived

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Atazanavir and Lamivudine for Treatment Simplification

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