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

NCT ID: NCT00544128

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-02-29

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.

Detailed Description

In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.

The primary endpoint is the antiretroviral effect over 48 weeks.

The secondary endpoints are;

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

2. Reasons of treatment failure by 144th week

3. Adverse events and their rate of incidence by 144th week

4. Serum concentration of tenofovir in selected patients

5. Serum concentration of atazanavir in selected patients

6. Renal complication in tenofovir arm

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epzicom Arm

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

Group Type: ACTIVE_COMPARATOR

lamivudine, abacavir , ritonavir, atazanavir

Intervention Type: DRUG

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

Truvada Arm

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

Group Type: ACTIVE_COMPARATOR

emtricitabine, tenofovir, ritonavir, atazanavir

Intervention Type: DRUG

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

Interventions

lamivudine, abacavir , ritonavir, atazanavir

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

Intervention Type: DRUG

emtricitabine, tenofovir, ritonavir, atazanavir

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;

1. alanine aminotransferase is more than 2.5 times higher of upper normal limit

2. estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation

3. 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

International Medical Center of Japan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shinichi Oka, M.D.

Shinichi Oka, Director general, AIDS Clinical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shinichi Oka, MD

Role: STUDY_CHAIR

International Medical Center of Japan

Locations

International Medical Center of Japan

Shinjuku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 23545667 (View on PubMed)

Other Identifiers

ET001

Identifier Type: -

Identifier Source: secondary_id

IMCJ-H19-466

Identifier Type: -

Identifier Source: org_study_id