Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00648999

Enrollment

207

Registered

2008-04-01

Start date

2003-11-30

Completion date

2006-12-31

Last updated

2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

Kaletra

Brief summary

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.

Interventions

DRUGlopinavir/ritonavir

lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Quality of Life	Baseline, Week 4, Week 24 and Week 48
CD4	Baseline, Week 24 and Week 48

Secondary

Measure	Time frame
Adverse Event Monitoring	Baseline, Week 4, Week 24 and Week 48

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026