DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
Primary Purpose
HIV Infections, AIDS
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
efavirenz, stavudine extended release, lamivudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116116
Brief Title
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS
Keywords
HIV/AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
efavirenz, stavudine extended release, lamivudine
Primary Outcome Measure Information:
Title
Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
Title
proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
Secondary Outcome Measure Information:
Title
Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
Title
Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
Title
Determine viral suppression of plasma HIV RNA change in baseline at week 48
Title
Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
Title
Evaluate time to undetectable plasma HIV RNA
Title
Evaluate proportion of patients demonstrating virologic breakthrough
Title
Evaluate proportion of patients demonstrating virologic failure
Title
Evaluate time to virologic breakthrough and virologic failure
Title
Measure magnitude and durability of changes in CD4 cell counts
Title
Evaluate patient adherence with QD regimen using pill counts and AMAF
Title
Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
Title
Explore QoL changes using MOS-HIV health survey
Title
Evaluate safety and tolerability of QD regimen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Local Institution
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Local Institution
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20133268
Citation
Jayaweera D, Dejesus E, Nguyen KL, Grimm K, Butcher D, Seekins DW. Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naive HIV-1-infected patients over 96 weeks. HIV Clin Trials. 2009 Nov-Dec;10(6):375-84. doi: 10.1310/hct1006-375.
Results Reference
background
PubMed Identifier
20133267
Citation
Nunes EP, Santini de Oliveira M, Mercon M, Zajdenverg R, Faulhaber JC, Pilotto JH, Ribeiro JE, Norton M, Schechter M. Monotherapy with Lopinavir/Ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clin Trials. 2009 Nov-Dec;10(6):368-74. doi: 10.1310/hct1006-368.
Results Reference
derived
Learn more about this trial
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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