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

Phase 4

Completed

• Conditions: HIV Infections; AIDS

• Registration Number: NCT00116116
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-06-27
• Study First Submitted QC: 2005-06-27
• Study First Posted: 2005-06-28
• Disposition First Submitted: 2010-01-27
• Disposition First Submitted QC: 2010-01-27
• Disposition First Posted: 2010-02-15
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Dallas, Texas, United States