DART I - 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:
NCT00116415
First received: June 29, 2005
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention
HIV Infections
AIDS
Drug: efavirenz; didanosine EC; lamivudine

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 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 48 weeks

Secondary Outcome Measures:
  • Evaluate proportion of patients with plasma HIV RNA <400 copies/mL at Weeks 24, 48, 72, and 96.
  • Evaluate proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96
  • Determine viral suppression of plasma HIV RNA from change in baseline at week 48
  • Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks
  • 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 patients experiencing virologic failure
  • Explore QoL changes using MOS-HIV health survey
  • Evaluate safety and tolerability of QD regimen

Estimated Enrollment: 65
Study Start Date: March 2002
Study Completion Date: November 2004
Primary Completion Date: November 2004 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116415

Locations
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Orlando, Florida, United States
United States, Georgia
Local Institution
Columbus, Georgia, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
United States, Missouri
Local Institution
Kansas City, Missouri, United States
United States, New Jersey
Local Institution
Hillsborough, New Jersey, United States
United States, New York
Local Institution
Bronx, New York, United States
United States, Texas
Local Institution
Dallas, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00116415     History of Changes
Other Study ID Numbers: AI266-071
Study First Received: June 29, 2005
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

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
Didanosine
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 July 20, 2014