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

Condition(s) targeted: HIV Infections; AIDS

Intervention: efavirenz, stavudine extended release, lamivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

Official title: Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Subjects

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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 outcome:

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

Evaluate safety and tolerability of QD regimen

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Local Institution, San Francisco, California, United States

Local Institution, Bakersfield, California, United States

Local Institution, Washington, District of Columbia, United States

Local Institution, Miami, Florida, United States

Local Institution, Ft. Lauderdale, Florida, United States

Local Institution, Jacksonville, Florida, United States

Local Institution, New York, New York, United States

Local Institution, Greenville, North Carolina, United States

Local Institution, Oklahoma City, Oklahoma, United States

Local Institution, Dallas, Texas, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: March 2002
Last updated: August 22, 2007