Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

NCT00544128 | Completed Phase 4 DMC

• 2 other identifiers: IMCJ-H19-466ET001
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

Conditions

HIV Infections

Keywords

HIV; initial therapy; once daily; randomized trial; non inferiority; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• antiretroviral effect over 48 weeks

  48 weeks

Secondary Outcomes (3)

• The immunologic effects from baseline at the 48th and 144th week

  144 weeks

• Reasons of treatment failure by 144th week

  144 weeks

• Adverse events and their rate of incidence by 144th week

  144 weeks

Study Arms (2)

Epzicom Arm

ACTIVE COMPARATOR

Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg

Drug: lamivudine, abacavir , ritonavir, atazanavir

Truvada Arm

ACTIVE COMPARATOR

Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg

Drug: emtricitabine, tenofovir, ritonavir, atazanavir

Interventions

lamivudine, abacavir , ritonavir, atazanavir DRUG

Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg

Epzicom Arm

emtricitabine, tenofovir, ritonavir, atazanavir DRUG

Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.

Truvada Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of HIV infection,
• Antiretroviral initiation is recommended by current clinical guidelines,
• Treatment naïve,
• Age over 20 years old Japanese,
• Able to obtain written informed consent

You may not qualify if:

• Current malabsorption condition,
• Prior use of lamivudine for hepatitis B treatment,
• Positive serology of Hepatitis B surface antigen,
• Patients who have following abnormal laboratory results within 6 weeks prior enrollment;
• alanine aminotransferase is more than 2.5 times higher of upper normal limit
• estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
• serum phosphate level is less than 2.0mg/dl
• Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
• Patients in pregnancy or breat feeding
• Patients who are taking medications contraindicated combine use of study medicine
• Patients whose primary care physicians consider inadequate to be enroll the study

Sponsors & Collaborators

• International Medical Center of Japan: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator

Study Sites (1)

International Medical Center of Japan

Shinjuku, Tokyo, 1628655, Japan

Location

Related Publications (1)

• Nishijima T, Takano M, Ishisaka M, Komatsu H, Gatanaga H, Kikuchi Y, Endo T, Horiba M, Kaneda S, Uchiumi H, Koibuchi T, Naito T, Yoshida M, Tachikawa N, Ueda M, Yokomaku Y, Fujii T, Higasa S, Takada K, Yamamoto M, Matsushita S, Tateyama M, Tanabe Y, Mitsuya H, Oka S; Epzicom-Truvada study team. Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial. Intern Med. 2013;52(7):735-44. doi: 10.2169/internalmedicine.52.9155. Epub 2013 Apr 1.

  PMID: 23545667 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Lamivudine; abacavir; Ritonavir; Atazanavir Sulfate; Emtricitabine; Tenofovir

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

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shinichi Oka, MD

  International Medical Center of Japan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shinichi Oka, Director general, AIDS Clinical Center

Study Record Dates

• First Submitted: October 12, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

JP (1)