Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

Condition(s) targeted: HIV Infection

Intervention: Tenofovir DF (Drug); lopinavir/ritonavir with 2 Nucleoside RTIs (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Umberto di Luzio Paparatti, MD, Study Director, Affiliation: Abbott

The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.

Official title: A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Antiviral efficacy by HIV RNA

Incidence of adverse events

Secondary outcome: Adherence and quality of life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV positive

- >18 years of age

- HIV RNA> 400 copies/mL

- Any CD 4 cell count

- Antiretroviral naïve

- No acute illness

Exclusion Criteria:

-

Global Medical Information-Abbott, Abbott Park, Illinois 60064, United States

Starting date: January 2005
Last updated: March 9, 2008