Clinical trial NCT00116415: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
AIDS
Keywords: HIV/AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-06-30
Enrollment: 65
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 efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) 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 ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 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 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 from change in baseline at week 48
measure: Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks
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 patients experiencing virologic failure
measure: Explore QoL changes using MOS-HIV health survey
measure: Evaluate safety and tolerability of QD regimen
Other outcomes:
Locations:
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Columbus
country: United States
facility: Local Institution
state: Georgia
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: Hillsborough
country: United States
facility: Local Institution
state: New Jersey
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Dallas
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
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.