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

NCT ID: NCT00280969

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-09-30

Brief 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)

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

atazanavir arm

Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.

Group Type: EXPERIMENTAL

atazanavir arm

Intervention Type: DRUG

Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.

efavirenz arm

Patients are treated with efavirenz 300mg along with Epzicom.

Group Type: ACTIVE_COMPARATOR

efavirenz

Intervention Type: DRUG

Patients are treated with efavirenz 300mg along with Epzicom.

Interventions

atazanavir arm

Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.

Intervention Type: DRUG

efavirenz

Patients are treated with efavirenz 300mg along with Epzicom.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role: collaborator

International Medical Center of Japan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shinichi Oka, M.D.

Director general, AIDS Clinical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shinichi Oka, M.D., phD.

Role: STUDY_CHAIR

International Medical Center of Japan

Locations

International Medical Center of Japan

Shinjuku, Tokyo, Japan

Countries

Japan

References

Honda M, Ishisaka M, Ishizuka N, Kimura S, Oka S; Japanese Anti-HIV-1 QD Therapy Study Group. Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Intern Med. 2011;50(7):699-705. doi: 10.2169/internalmedicine.50.4572. Epub 2011 Apr 1.

Reference Type: RESULT

PMID: 21467701 (View on PubMed)

Other Identifiers

QD001

Identifier Type: -

Identifier Source: org_study_id