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

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Didanosine; Efavirenz; Lamivudine

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