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

International Medical Center of Japan

Status and phase

Completed

Phase 3

Conditions

HIV Infection

Treatments

Drug: atazanavir arm

Drug: efavirenz

Study type

Interventional

Funder types

Other

Identifiers

NCT00280969

QD001

Details and patient eligibility

About

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)

Full description

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.

Enrollment

71 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.