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

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: Tenofovir DF Drug: lopinavir/ritonavir with 2 Nucleoside RTIs	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Tenofovir Ritonavir Lopinavir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Antiviral efficacy by HIV RNA [ Time Frame: 72 wks ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: 72 wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adherence and quality of life [ Time Frame: 72 wks ] [ Designated as safety issue: No ]


Enrollment:	152
Study Start Date:	January 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 2 drug arm	Drug: Tenofovir DF TDF 300mg QD for 72 wks Drug: lopinavir/ritonavir with 2 Nucleoside RTIs LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks Other Names: ABT-378 Kaletra lopinavir/ritonavir
Active Comparator: B 3 drug arm, SOC	Drug: lopinavir/ritonavir with 2 Nucleoside RTIs LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks Other Names: ABT-378 Kaletra lopinavir/ritonavir

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234910

Locations


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

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Umberto di Luzio Paparatti, MD	Abbott

More Information


Responsible Party:	Dr. Umberto di Luzio Paparatti, Medical Director Abbott Italy, Abbott
ClinicalTrials.gov Identifier:	NCT00234910 History of Changes
Other Study ID Numbers:	ITAL-04-002 EUDRACT 2004-000786-35 KALEAD
Study First Received:	September 13, 2005
Last Updated:	July 9, 2008
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Abbott:


Lopinavir Ritonavir Kaletra	Tenofovir HIV infection Treatment Naive

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016

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