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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00116116
First received: June 27, 2005
Last updated: April 14, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
AIDS
 Drug: efavirenz, stavudine extended release, lamivudine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 70
Study Start Date: March 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116116

Locations
United States, California
Local Institution
Bakersfield, California, United States
Local Institution
San Francisco, California, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Ft. Lauderdale, Florida, United States
Local Institution
Jacksonville, Florida, United States
Local Institution
Miami, Florida, United States
United States, New York
Local Institution
New York, New York, United States
United States, North Carolina
Local Institution
Greenville, North Carolina, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
United States, Texas
Local Institution
Dallas, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00116116     History of Changes
Other Study ID Numbers: AI455-131
Study First Received: June 27, 2005
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Stavudine
Lamivudine
 Efavirenz
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013