DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

Bristol-Myers Squibb70 enrolled

Overview

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections AIDS

Interventions

efavirenz, stavudine extended release, lamivudineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age or older infected with HIV and weigh at least 40 kg. * Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater. * Be willing to use two forms of contraception throughout study. * No previous exposure to antiretroviral (ARV) drugs Exclusion Criteria: * Pregnancy or breastfeeding * Physical or psychiatric disability * Proven or suspected acute hepatitis within 30 days prior to study entry * Active AIDS-defining opportunistic infection or disease * History of acute or chronic pancreatitis

Locations (10)

Local Institution

Bakersfield, California, United States

Local Institution

San Francisco, California, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Outcomes

Primary Outcomes

Estimate efficacy of d4T-XR/3TC/EFV given QD determined by

proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks

Secondary Outcomes

Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96

Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96

Determine viral suppression of plasma HIV RNA change in baseline at week 48

Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation

Evaluate time to undetectable plasma HIV RNA

Evaluate proportion of patients demonstrating virologic breakthrough

Evaluate proportion of patients demonstrating virologic failure

Evaluate time to virologic breakthrough and virologic failure

Measure magnitude and durability of changes in CD4 cell counts

Evaluate patient adherence with QD regimen using pill counts and AMAF

Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure

Explore QoL changes using MOS-HIV health survey

Data from ClinicalTrials.gov

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