DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Didanosine Lamivudine Efavirenz

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 (Adult, Senior)
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

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: 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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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-Naïve 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, Merçon 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.


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:


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 Didanosine 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 September 26, 2016