Atazanavir and Lamivudine for Treatment Simplification

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Lamiduvine (Epivir); Drug: Atazanavir (Reyataz); Drug: Ritonavir (Norvir)

• Registration Number: NCT00885482
• Lead Sponsor: Catholic University of the Sacred Heart

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 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.

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.

Study Timeline

• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-22
• Study Start: 2009-05
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2015-02
• Results First Submitted: 2015-02-04
• Results First Submitted QC: 2015-02-04
• Results First Posted: 2015-02-23
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Ritonavir (Norvir)	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.
Single arm	Atazanavir (Reyataz)	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.
Single arm	Lamiduvine (Epivir)	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.

Primary Outcome Measures

Name	Time	Method
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	48 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy