Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

This study is currently recruiting patients.
Verified by GlaxoSmithKline November 2005

Purpose

The purpose of this study is to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects

Further Study Details: 

Primary Outcomes: Establish abacavir/lamivudine as comparable to emtricitabine/tenofovir, both in combination with lopinavir/ritonavir, based on proportions with HIV RNA <50 copies/mL at Week 48 and adverse events over 96 weeks.
Secondary Outcomes: Proportions with HIV RNA <50 and <400 copies/mL at Weeks 48 and 96, Adverse events over 48 weeks.
Expected Total Enrollment:  680

Study start: July 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Diagnosed with HIV infection.
• Must have a viral load of at least 1,000 copies/mL.

Exclusion criteria:

• Have received previous treatment with any anti-HIV medications.
• Female patients of childbearing potential who are be pregnant, or breastfeeding, or planning to become pregnant during the 2 year study.

(All patients must agree to use adequate contraception throughout the 2 year study.)

• Have an active AIDS condition, pancreatitis, poor kidney function, or clinically active hepatitis.
• Have certain medical conditions that may make participation unsafe.
• Take medications that may interact with the study medications.

Location and Contact Information

Circle Medical LLC, Norwalk, Connecticut, 06851; Gary Blick, MD (203) 852-9525; Status: Recruiting
Or use our Study Signup page for more information for you or your patients.