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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: AIDS; HIV Infections

Treatments: Drug: efavirenz; didanosine EC; lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116415

AI266-071

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)