DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
Completed · Phase 4
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 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.
Key facts
- Study ID
- NCT00116116
- Run by
- Bristol-Myers Squibb
- People needed
- 70
- Starts
- 2002-03-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2011-04-26
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 — Bakersfield, California, United States
- Local Institution — San Francisco, California, United States
- Local Institution — Washington D.C., District of Columbia, United States
- Local Institution — Fort Lauderdale, Florida, United States
- Local Institution — Jacksonville, Florida, United States
- Local Institution — Miami, Florida, United States
- Local Institution — New York, New York, United States
- Local Institution — Greenville, North Carolina, United States
- Local Institution — Oklahoma City, Oklahoma, United States
- Local Institution — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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