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

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

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

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.

Estado general Completed
Fecha de inicio March 2002
Fecha de Terminación June 2005
Fecha de finalización primaria June 2005
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 70
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: efavirenz, stavudine extended release, lamivudine

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Local Institution | Bakersfield, California, United States
Local Institution | San Francisco, California, United States
Local Institution | Washington, District of Columbia, United States
Local Institution | Ft. Lauderdale, Florida, United States
Local Institution | Jacksonville, Florida, United States
Local Institution | Miami, 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
Ubicacion Paises

United States

Fecha de verificación

April 2011

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov