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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

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ClinicalTrials.gov Identifier: NCT00116116
Recruitment Status : Completed
First Posted : June 28, 2005
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections AIDS Drug: efavirenz, stavudine extended release, lamivudine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
  2. proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks

Secondary Outcome Measures :
  1. Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
  2. Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
  3. Determine viral suppression of plasma HIV RNA change in baseline at week 48
  4. Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
  5. Evaluate time to undetectable plasma HIV RNA
  6. Evaluate proportion of patients demonstrating virologic breakthrough
  7. Evaluate proportion of patients demonstrating virologic failure
  8. Evaluate time to virologic breakthrough and virologic failure
  9. Measure magnitude and durability of changes in CD4 cell counts
  10. Evaluate patient adherence with QD regimen using pill counts and AMAF
  11. Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
  12. Explore QoL changes using MOS-HIV health survey
  13. Evaluate safety and tolerability of QD regimen

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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:

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
First Posted: June 28, 2005    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Efavirenz
Stavudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Antimetabolites