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Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment

Information source: International Medical Center of Japan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: atazanavir arm (Drug); efavirenz (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: International Medical Center of Japan

Official(s) and/or principal investigator(s):
Shinichi Oka, M.D., phD., Study Chair, Affiliation: International Medical Center of Japan

Summary

A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)

Clinical Details

Official title: Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz

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

Primary outcome: Antiretroviral effect at the 48th week

Secondary outcome:

1. Evaluation of immunological effect and safety in 48 weeks.

2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Detailed description: A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz) The primary endpoint is antiretroviral effect at the 48th week. The secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2. Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- serological diagnosis of HIV infection

- male aged over 20 years old

- CD4 at enrollment between 100 to 300

- body weight over 40kg

- enable to obtain the written informed consent

Exclusion Criteria:

- Patients who are considered unable to complete 48 weeks of study by their physician.

- Patients who have gastrointestinal symptom which may interfere the absorption of

antiretrovirals, or have swallowing problems.

- Patients who have the history of hypersensitivity with lamivudine.

- Hepatitis B carrier.

- Blood test results within 4 weeks prior to the randomization; hemoglobin less than

9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2. 0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1. 2mg/dl.

- Patients who have had radiation or chemotherapy within 4 weeks prior to the

randomization or will have the treatment during the study .

- Patients who have had immunomodulating agent such as systemic use of corticosteroid

or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception.

- Patients who have diabetes, congestive heart failure, cardiomyopathy, or other

serious medical condition.

- Patients with AIDS defining illness.

- Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine

and abacavir prior to the study.

- Patients with acute retroviral syndrome.

- Patients with psychiatric disorder.

- Patients whose physician consider the study enrollment inappropriate.

Locations and Contacts

International Medical Center of Japan, Shinjuku, Tokyo 162-8655, Japan
Additional Information

Starting date: September 2005
Last updated: March 27, 2015

Page last updated: August 23, 2015

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