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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ClinicalTrials.gov Identifier: NCT00116116 |
Recruitment Status
:
Completed
First Posted
: June 28, 2005
Last Update Posted
: April 26, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections AIDS | Drug: efavirenz, stavudine extended release, lamivudine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 70 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | June 2005 |

- Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
- proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116116
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 |
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 |
First Posted: | June 28, 2005 Key Record Dates |
Last Update Posted: | April 26, 2011 |
Last Verified: | April 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 |