Atazanavir and Lamivudine for Treatment Simplification

HIV Infections Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885482
• Other study ID #: 2009-011273-32
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2009
• Last updated: February 23, 2015
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: February 2015
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamiduvine (Epivir)
Epivir 300 mg
• Atazanavir (Reyataz)
Reyataz 300 mg
• Ritonavir (Norvir)
Norvir 100 mg

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Virological Failure at Survival Analysis		48 weeks	No
Secondary	Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis		48 weeks	No
Secondary	Evolution of CD4 Cell Count During the 48 Weeks		48 weeks	No
Secondary	Evolution of Adherence and Quality of Life During the 48 Weeks		48 weeks	Yes
Secondary	Evolution of Atazanavir Plasma Concentrations During the 48 Weeks		48 weeks	No
Secondary	Change of Metabolic Parameters at 48 Weeks		48 weeks	Yes
Secondary	Change of the Results of Neurocognitive Tests at 48 Weeks		48 weeks	Yes
Secondary	Change of Bone Density and of Subcutaneous Fat at 48 Weeks		48 weeks	Yes