- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116415
DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
April 8, 2011 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
65
Phase
- Not Applicable
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
-
-
District of Columbia
-
Washington, District of Columbia, United States
- Local Institution
-
-
Florida
-
Orlando, Florida, United States
- Local Institution
-
-
Georgia
-
Columbus, Georgia, United States
- Local Institution
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Local Institution
-
Springfield, Massachusetts, United States
- Local Institution
-
-
Missouri
-
Kansas City, Missouri, United States
- Local Institution
-
-
New Jersey
-
Hillsborough, New Jersey, United States
- Local Institution
-
-
New York
-
Bronx, New York, United States
- Local Institution
-
-
Texas
-
Dallas, Texas, United States
- Local Institution
-
-
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 |
---|
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
Outcome Measure |
---|
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
|
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
- 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.
- 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.
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)
November 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
June 29, 2005
First Submitted That Met QC Criteria
June 29, 2005
First Posted (Estimate)
June 30, 2005
Study Record Updates
Last Update Posted (Estimate)
April 22, 2011
Last Update Submitted That Met QC Criteria
April 8, 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
- Didanosine
- Efavirenz
Other Study ID Numbers
- AI266-071
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.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on efavirenz; didanosine EC; lamivudine
-
Tuberculosis Research Centre, IndiaIndian Council of Medical Research; National AIDS Control OrganisationUnknownTuberculosis | Human Immunodeficiency Virus InfectionsIndia
-
Harvard School of Public Health (HSPH)Bristol-Myers Squibb; McGill University Health Centre/Research Institute of... and other collaboratorsCompleted
-
Clinical Trial Agency of HIV Study GroupCompleted
-
French National Agency for Research on AIDS and...CompletedHIV InfectionVietnam
-
French National Agency for Research on AIDS and...CompletedHIV Infections | AIDSBurkina Faso
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States, Puerto Rico, Italy
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Terminated
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico
-
National Institute of Allergy and Infectious Diseases...Completed
-
The HIV Netherlands Australia Thailand Research...Khon Kaen UniversityActive, not recruiting