Clinical trial NCT00544128: Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
initial therapy
once daily
randomized trial
non inferiority
Treatment Naive
Lead sponsor: International Medical Center of Japan
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2007-10-16
Enrollment: 109
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: antiretroviral effect over 48 weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: The immunologic effects from baseline at the 48th and 144th week
timeFrame: 144 weeks
measure: Reasons of treatment failure by 144th week
timeFrame: 144 weeks
measure: Adverse events and their rate of incidence by 144th week
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: International Medical Center of Japan
state: Tokyo
Study officials:
affiliation: International Medical Center of Japan
name: Shinichi Oka, MD
role: STUDY_CHAIR
References:
citation: 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.