Atazanavir and Lamivudine for Treatment Simplification

NCT00885482 | Completed Phase 4 Results

• 1 other identifier: 2009-011273-32
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of the study:

1. 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. 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.

Conditions

HIV Infections

Keywords

HIV/AIDS; HAART; Simplification; Atazanavir; Lamivudine; treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time to Virological Failure at Survival Analysis

  48 weeks

• Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis

  48 weeks

• Evolution of CD4 Cell Count During the 48 Weeks

  48 weeks

• Evolution of Adherence and Quality of Life During the 48 Weeks

  48 weeks

• Evolution of Atazanavir Plasma Concentrations During the 48 Weeks

  48 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Drug: Lamiduvine (Epivir); Drug: Atazanavir (Reyataz); Drug: Ritonavir (Norvir)

Interventions

Lamiduvine (Epivir) DRUG

Epivir 300 mg

Single arm

Atazanavir (Reyataz) DRUG

Reyataz 300 mg

Single arm

Ritonavir (Norvir) DRUG

Norvir 100 mg

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 21329725 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Lamivudine; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Results Point of Contact

• Title: Andrea De Luca
• Organization: Catholic University of S. Heart

deluca.andrea@fastwebnet.it

+390630155366

Study Officials

• Andrea De Luca, MD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: March 13, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

IT (1)