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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116116
• Other study ID #: AI455-131
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2005
• Last updated: April 14, 2011
• Start date: March 2002
• Est. completion date: June 2005

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• efavirenz, stavudine extended release, lamivudine

Locations

Country	Name	City	State
United States	Local Institution	Bakersfield	California
United States	Local Institution	Dallas	Texas
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Greenville	North Carolina
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Miami	Florida
United States	Local Institution	New York	New York
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	San Francisco	California
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
Primary	proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
Secondary	Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
Secondary	Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
Secondary	Determine viral suppression of plasma HIV RNA change in baseline at week 48
Secondary	Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
Secondary	Evaluate time to undetectable plasma HIV RNA
Secondary	Evaluate proportion of patients demonstrating virologic breakthrough
Secondary	Evaluate proportion of patients demonstrating virologic failure
Secondary	Evaluate time to virologic breakthrough and virologic failure
Secondary	Measure magnitude and durability of changes in CD4 cell counts
Secondary	Evaluate patient adherence with QD regimen using pill counts and AMAF
Secondary	Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
Secondary	Explore QoL changes using MOS-HIV health survey
Secondary	Evaluate safety and tolerability of QD regimen

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm