DART II - 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 and phase: Completed; Phase 4

Conditions: AIDS; HIV Infections

Treatments: Drug: efavirenz, stavudine extended release, lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116116

AI455-131

Details and patient eligibility

About

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.

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)