Status:
COMPLETED
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00116116
Start Date
March 1 2002
End Date
June 1 2005
Last Update
April 26 2011
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Bakersfield, California, United States
2
Local Institution
San Francisco, California, United States
3
Local Institution
Washington D.C., District of Columbia, United States
4
Local Institution
Fort Lauderdale, Florida, United States