Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

NCT01097655 | Completed Results

• 1 other identifier: P06-131
• Study Type: observational
• Target: 3,049
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.

Conditions

Human Immunodeficiency Virus

Keywords

Tablets; Infection; Non Nucleoside Reverse Transcriptase Inhibitor; Tolerability; Viral load; Human immunodeficiency Virus; Effectiveness; Treatment-naïve

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count

  Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.

  Baseline (Week 0) to Week 144

• Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load

  Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.

  Baseline (Week 0) to Week 144

Other Outcomes (2)

• Prevalence of Adverse Events (Weeks 0-144), Per Event

  Weeks 0 to 144

• Prevalence of Adverse Events (Weeks 0-144), Per Participant

  Weeks 0 to 144

Study Arms (1)

HIV-infected Participants

HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: * antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets * participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen * participants pretreated with a PI-containing regimen (apart from Kaletra).

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Community sample; HIV-infected patients * For Belgium: AIDS references centers (probability sample)

You may qualify if:

• Patients with HIV infection
• Patients that will be treated with Kaletra tablets independent from their participation in this study

You may not qualify if:

• Hypersensitivity against Kaletra or other ingredients
• Severe liver insufficiency
• No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
• Patients who received more than 1 protease inhibitor during their therapy history

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Veeda Clinical Research: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

800-633-9110

Study Officials

• Sandra Bloch, MD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: April 2, 2010
• Study Start: August 1, 2006
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-05