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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

June 27, 2005
April 14, 2011
March 2002
June 2005   (final data collection date for primary outcome measure)
  • Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
  • proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
Not Provided
Complete list of historical versions of study NCT00116116 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
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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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Drug: efavirenz, stavudine extended release, lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116116
AI455-131
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP