- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116116
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
April 14, 2011 updated by: Bristol-Myers Squibb
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Bakersfield, California, United States
- Local Institution
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San Francisco, California, United States
- Local Institution
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District of Columbia
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Washington, District of Columbia, United States
- Local Institution
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Florida
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Ft. Lauderdale, Florida, United States
- Local Institution
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Jacksonville, Florida, United States
- Local Institution
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Miami, Florida, United States
- Local Institution
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New York
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New York, New York, United States
- Local Institution
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North Carolina
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Greenville, North Carolina, United States
- Local Institution
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Local Institution
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Texas
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Dallas, Texas, United States
- Local Institution
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
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proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
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Secondary Outcome Measures
Outcome Measure |
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Evaluate time to undetectable plasma HIV RNA
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Evaluate proportion of patients demonstrating virologic breakthrough
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Evaluate proportion of patients demonstrating virologic failure
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Evaluate time to virologic breakthrough and virologic failure
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Measure magnitude and durability of changes in CD4 cell counts
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Evaluate patient adherence with QD regimen using pill counts and AMAF
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Explore QoL changes using MOS-HIV health survey
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Evaluate safety and tolerability of QD regimen
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Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
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Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
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Determine viral suppression of plasma HIV RNA change in baseline at week 48
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Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
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Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
June 27, 2005
First Submitted That Met QC Criteria
June 27, 2005
First Posted (Estimate)
June 28, 2005
Study Record Updates
Last Update Posted (Estimate)
April 26, 2011
Last Update Submitted That Met QC Criteria
April 14, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Lamivudine
- Stavudine
- Efavirenz
Other Study ID Numbers
- AI455-131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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