DART I - 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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00116415
First received: June 29, 2005
Last updated: April 8, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections AIDS |
Drug: efavirenz; didanosine EC; lamivudine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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:
- 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
| Estimated Enrollment: | 65 |
| Study Start Date: | March 2002 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116415
Locations
| United States, District of Columbia | |
| Local Institution | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Local Institution | |
| Orlando, Florida, United States | |
| United States, Georgia | |
| Local Institution | |
| Columbus, Georgia, United States | |
| United States, Massachusetts | |
| Local Institution | |
| Boston, Massachusetts, United States | |
| Local Institution | |
| Springfield, Massachusetts, United States | |
| United States, Missouri | |
| Local Institution | |
| Kansas City, Missouri, United States | |
| United States, New Jersey | |
| Local Institution | |
| Hillsborough, New Jersey, United States | |
| United States, New York | |
| Local Institution | |
| Bronx, New York, United States | |
| United States, Texas | |
| Local Institution | |
| Dallas, Texas, United States | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00116415 History of Changes |
| Other Study ID Numbers: | AI266-071 |
| Study First Received: | June 29, 2005 |
| Last Updated: | April 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bristol-Myers Squibb:
|
HIV/AIDS |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Didanosine Lamivudine |
Efavirenz Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013