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

Primary Purpose

HIV Infections, AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
efavirenz; didanosine EC; lamivudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

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

Full Information

First Posted
June 29, 2005
Last Updated
April 8, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00116415
Brief Title
DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS
Keywords
HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
efavirenz; didanosine EC; lamivudine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate proportion of patients with plasma HIV RNA <400 copies/mL at Weeks 24, 48, 72, and 96.
Title
Evaluate proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96
Title
Determine viral suppression of plasma HIV RNA from change in baseline at week 48
Title
Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks
Title
Evaluate time to undetectable plasma HIV RNA
Title
Evaluate proportion of patients demonstrating virologic breakthrough
Title
Evaluate proportion of patients demonstrating virologic failure
Title
Evaluate time to virologic breakthrough and virologic failure
Title
Measure magnitude and durability of changes in CD4 cell counts
Title
Evaluate patient adherence with QD regimen using pill counts and AMAF
Title
Determine pattern and emergence of HIV genotype resistance mutations in patients experiencing virologic failure
Title
Explore QoL changes using MOS-HIV health survey
Title
Evaluate safety and tolerability of QD regimen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Local Institution
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Bronx
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20133268
Citation
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.
Results Reference
derived
PubMed Identifier
20133267
Citation
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.
Results Reference
derived

Learn more about this trial

DART I - 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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