Evaluation of Kaletra Therapy Over the Long-term

Abbott

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Lopinavir/Ritonavir (Kaletra)

Study type: Observational

Funder types: Industry

Identifiers

NCT01083810

KAL 1 RO

Details and patient eligibility

About

Long term observation of patients under lopinavir/ritonavir containing therapy

Full description

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients infected by HIV-1
• Age greater than or equal to 18 years

Exclusion criteria

• as described in SmPC (summary of product characteristics) at the time of prescription

Trial design

284 participants in 3 patient groups

therapy-naive

Description:

Patients who had not received prior antiretroviral drug therapy

Treatment:

Drug: Lopinavir/Ritonavir (Kaletra)

pre-treated

Description:

Patients that had previously received antiretroviral therapy, but are protease inhibitor naive

Treatment:

Drug: Lopinavir/Ritonavir (Kaletra)

non-B

Description:

Patients infected with non-B subtypes of HIV-1

Treatment:

Drug: Lopinavir/Ritonavir (Kaletra)