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

HIV Infections Clinical Trial

Official title:

A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544128
• Other study ID #: IMCJ-H19-466
• Secondary ID: ET001
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2007
• Last updated: March 27, 2015
• Start date: October 2007
• Est. completion date: February 2012

Study information

• Verified date: March 2015
• Source: International Medical Center of Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• lamivudine, abacavir , ritonavir, atazanavir
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
• emtricitabine, tenofovir, ritonavir, atazanavir
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.

Locations

Country	Name	City	State
Japan	International Medical Center of Japan	Shinjuku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
International Medical Center of Japan	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & 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, Mitsu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antiretroviral effect over 48 weeks		48 weeks	Yes
Secondary	The immunologic effects from baseline at the 48th and 144th week		144 weeks	Yes
Secondary	Reasons of treatment failure by 144th week		144 weeks	Yes
Secondary	Adverse events and their rate of incidence by 144th week		144 weeks	Yes