Clinical trial NCT01075191: Kaletra: Therapy With Double Protease Inhibitors
Official title: PMOS: Kaletra Double Protease Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Viral load
Resistance
Double protease inhibitors
Mutations
Immune system
Infection
Nucleoside Reverse Transcriptase Inhibitors-free
Human Immunodeficiency Virus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample; Human Immunodeficiency Virus-infected participants

Brief summary: Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Detailed description: This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

Eligibility criteria: Inclusion Criteria:

* Participants with Human Immunodeficiency Virus infection
* Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion Criteria:

* Hypersensitivity against lopinavir, ritonavir or other ingredients
* Severe liver insufficiency
* No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

Primary outcomes:
measure: Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Secondary outcomes:
measure: Change From Baseline in Absolute CD4 Cell Count
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Change From Baseline in Relative CD4 Cell Count
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Change From Baseline in Absolute CD8 Cell Count
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Change From Baseline in Relative CD8 Cell Count
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Change From Baseline in CD4/CD8 T-cell Ratio
timeFrame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 48283
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28131
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 66422
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28123
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 28109
city: Dortmund
country: Germany
facility: Site Reference ID/Investigator# 28115
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 28124
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 28127
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 28119
city: Krefeld
country: Germany
facility: Site Reference ID/Investigator# 5318
city: Ludwigshafen
country: Germany
facility: Site Reference ID/Investigator# 28112
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 28111
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 28129
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 28118
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 28113
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 28133
city: Wuppertal
country: Germany
facility: Site Reference ID/Investigator# 28126
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Stefan Simianer, MD
role: STUDY_DIRECTOR
References: