Clinical trial NCT00116116: DART II - 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-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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
AIDS
Keywords: HIV/AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-06-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
measure: proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
Secondary outcomes:
measure: Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
measure: Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
measure: Determine viral suppression of plasma HIV RNA change in baseline at week 48
measure: Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
measure: Evaluate time to undetectable plasma HIV RNA
measure: Evaluate proportion of patients demonstrating virologic breakthrough
measure: Evaluate proportion of patients demonstrating virologic failure
measure: Evaluate time to virologic breakthrough and virologic failure
measure: Measure magnitude and durability of changes in CD4 cell counts
measure: Evaluate patient adherence with QD regimen using pill counts and AMAF
measure: Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
measure: Explore QoL changes using MOS-HIV health survey
measure: Evaluate safety and tolerability of QD regimen
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: New York
country: United States
facility: Local Institution
state: New York
city: Greenville
country: United States
facility: Local Institution
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Dallas
country: United States
facility: Local Institution
state: Texas
Study officials:
References:
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.
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.