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

Completed · Not applicable

Conditions studied: HIV Infections, AIDS

In brief

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.

Key facts

Study ID: NCT00116415
Run by: Bristol-Myers Squibb
People needed: 65
Starts: 2002-03-01
Expected to finish: 2004-11-01
Last updated by the study team: 2011-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Local Institution — Washington D.C., District of Columbia, United States
Local Institution — Orlando, Florida, United States
Local Institution — Columbus, Georgia, United States
Local Institution — Boston, Massachusetts, United States
Local Institution — Springfield, Massachusetts, United States
Local Institution — Kansas City, Missouri, United States
Local Institution — Hillsborough, New Jersey, United States
Local Institution — The Bronx, New York, United States
Local Institution — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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