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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280969
• Other study ID #: QD001
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2006
• Last updated: March 27, 2015
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: March 2015
• Source: International Medical Center of Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• atazanavir arm
Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.
• efavirenz
Patients are treated with efavirenz 300mg along with Epzicom.

Locations

Country	Name	City	State
Japan	International Medical Center of Japan	Shinjuku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
International Medical Center of Japan	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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-d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiretroviral effect at the 48th week		48 weeks	Yes
Secondary	1. Evaluation of immunological effect and safety in 48 weeks.		48 weeks	Yes
Secondary	2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.		96 weeks	Yes