Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment - Full Text View

Sponsors and Collaborators:	International Medical Center of Japan Japanese Ministry of Health, Labor and Welfare
Information provided by:	International Medical Center of Japan
ClinicalTrials.gov Identifier:	NCT00280969

Purpose

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)

Condition	Intervention	Phase
HIV Infection	Drug: atazanavir arm Drug: efavirenz	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Ritonavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open-Label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz

Further study details as provided by International Medical Center of Japan:

Primary Outcome Measures:

Antiretroviral effect at the 48th week [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1. Evaluation of immunological effect and safety in 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	71
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
atazanavir arm: Experimental Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.	Drug: atazanavir arm Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
efavirenz arm: Active Comparator Patients are treated with efavirenz 300mg along with Epzicom.	Drug: efavirenz Patients are treated with efavirenz 300mg along with Epzicom.

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

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280969

Locations

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

Sponsors and Collaborators

International Medical Center of Japan

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Shinichi Oka, M.D., phD.

International Medical Center of Japan

More Information

No publications provided

Responsible Party:	AIDS Clinical Center, International Medical Center of Japan ( Shinichi Oka, Director general )
Study ID Numbers:	QD001
Study First Received:	January 22, 2006
Last Updated:	June 22, 2008
ClinicalTrials.gov Identifier:	NCT00280969 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by International Medical Center of Japan:

HIV infection
treatment
efavirenz
atazanavir
ritonavir

Study placed in the following topic categories:

Efavirenz
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents

Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009