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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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00116116
First received: June 27, 2005
Last updated: April 14, 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 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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections AIDS | Drug: efavirenz, stavudine extended release, lamivudine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
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
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2002 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116116
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116116
Locations
| United States, California | |
| Local Institution | |
| Bakersfield, California, United States | |
| Local Institution | |
| San Francisco, California, United States | |
| United States, District of Columbia | |
| Local Institution | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Local Institution | |
| Ft. Lauderdale, Florida, United States | |
| Local Institution | |
| Jacksonville, Florida, United States | |
| Local Institution | |
| Miami, Florida, United States | |
| United States, New York | |
| Local Institution | |
| New York, New York, United States | |
| United States, North Carolina | |
| Local Institution | |
| Greenville, North Carolina, United States | |
| United States, Oklahoma | |
| Local Institution | |
| Oklahoma City, Oklahoma, United States | |
| United States, Texas | |
| Local Institution | |
| Dallas, Texas, United States | |
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00116116 History of Changes |
| Other Study ID Numbers: |
AI455-131 |
| Study First Received: | June 27, 2005 |
| Last Updated: | April 14, 2011 |
Keywords provided by Bristol-Myers Squibb:
|
HIV/AIDS |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Efavirenz Stavudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |
ClinicalTrials.gov processed this record on July 19, 2017