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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by International Medical Center of Japan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
International Medical Center of Japan
ClinicalTrials.gov Identifier:
NCT00280969
First received: January 22, 2006
Last updated: June 22, 2008
Last verified: June 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz

Resource links provided by NLM:


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
Experimental: atazanavir arm
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.
Active Comparator: efavirenz arm
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
International Medical Center of Japan
Shinjuku, Tokyo, Japan, 162-8655
Sponsors and Collaborators
International Medical Center of Japan
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Shinichi Oka, M.D., phD. International Medical Center of Japan
  More Information

No publications provided by International Medical Center of Japan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shinichi Oka, Director general, AIDS Clinical Center, International Medical Center of Japan
ClinicalTrials.gov Identifier: NCT00280969     History of Changes
Other Study ID Numbers: QD001
Study First Received: January 22, 2006
Last Updated: June 22, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by International Medical Center of Japan:
HIV infection
treatment
efavirenz
atazanavir
ritonavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Efavirenz
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014