Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00648999

Purpose

To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

Condition	Intervention	Phase
HIV Infections Kaletra	Drug: lopinavir/ritonavir Drug: lopinavir /ritonavir	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Phase IV Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]
CD4 [ Time Frame: Baseline, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]

Enrollment:	207
Study Start Date:	November 2003
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: lopinavir/ritonavir lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
2: Active Comparator	Drug: lopinavir /ritonavir lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV Infected subjects
Subjects failing in current HIV treatment, or
Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
Subject is pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648999

Locations

Mexico

Oaxaca, Mexico

Puebla, Mexico
Mexico, Chiapas

Tuxtla Gutierrez, Chiapas, Mexico
Mexico, Distrito Federal

Mexico City, Distrito Federal, Mexico
Mexico, Guanajauto

Leon, Guanajauto, Mexico
Mexico, Guerrero

Acapulco, Guerrero, Mexico
Mexico, Michoacan

Morelia, Michoacan, Mexico
Mexico, Morelia

Cuernavaca, Morelia, Mexico
Mexico, Nayarit

Tepic, Nayarit, Mexico
Mexico, Nueva Leon

Monterrey, Nueva Leon, Mexico
Mexico, Sinaloa

Culiacan, Sinaloa, Mexico
Mexico, Yucatan

Merida, Yucatan, Mexico

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Max Saráchaga / Medical Director )
Study ID Numbers:	MEXI-P01-02
Study First Received:	March 28, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00648999 History of Changes
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Abbott:

HIV

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009