Status:
COMPLETED
DART I - 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:
NA
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 ...
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 :
November 1 2004
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00116415
Start Date
March 1 2002
End Date
November 1 2004
Last Update
April 22 2011
Active Locations (9)
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1
Local Institution
Washington D.C., District of Columbia, United States
2
Local Institution
Orlando, Florida, United States
3
Local Institution
Columbus, Georgia, United States
4
Local Institution
Boston, Massachusetts, United States