Atazanavir and Lamivudine for Treatment Simplification (AtLaS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Catholic University of the Sacred Heart.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00885482
First received: April 20, 2009
Last updated: May 14, 2009
Last verified: April 2009

April 20, 2009
May 14, 2009
May 2009
August 2010   (final data collection date for primary outcome measure)
proportion 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885482 on ClinicalTrials.gov Archive Site
  • Time to virological failure at survival analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of CD4 cell count during the 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Evolution of adherence and quality of life during the 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Evolution of atazanavir plasma concentrations during the 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change of metabolic parameters at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change of the results of neurocognitive tests at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Change of bone density and of subcutaneous fat at 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Atazanavir and Lamivudine for Treatment Simplification
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.

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 with ritonavir.
  2. 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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lamiduvine (Epivir)
    Epivir 300 mg
  • Drug: Atazanavir (Reyataz)
    Reyataz 300 mg
  • Drug: Ritonavir (Norvir)
    Norvir 100 mg
Experimental: 1
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.
Interventions:
  • Drug: Lamiduvine (Epivir)
  • Drug: Atazanavir (Reyataz)
  • Drug: Ritonavir (Norvir)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andrea De Luca, MD 00390630154945 andrea.deluca@rm.unicatt.it
Italy
 
NCT00885482
2009−011273−32
No
Dr. Andrea De Luca, Catholic University of Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: Andrea De Luca, MD Catholic University of Sacred Heart
Catholic University of the Sacred Heart
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP