Evaluation of Kaletra Therapy Over the Long-term

NCT01083810 | Completed Results

• 1 other identifier: KAL 1 RO
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 90

Brief Summary

Long term observation of patients under lopinavir/ritonavir containing therapy

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus; Infection; Kaletra; Resistance; Mutations; alternative Therapy regimen

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs

  Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.

  Baseline and at any timepoint where testing is possible

Secondary Outcomes (5)

• Percentage of Patients With HIV-1 RNA <50 Copies/ml

  Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

• Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml

  Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

• Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml

  Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

• Percentage of Patients With HIV-1 RNA >500 Copies/ml

  Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

• Change in Absolute CD4 Cell Count [CD4+ Cells/µL]

  Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

Study Arms (3)

therapy-naive

Patients who had not received prior antiretroviral drug therapy

Drug: Lopinavir/Ritonavir (Kaletra)

pre-treated

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

Drug: Lopinavir/Ritonavir (Kaletra)

non-B

Patients infected with non-B subtypes of HIV-1

Drug: Lopinavir/Ritonavir (Kaletra)

Interventions

Lopinavir/Ritonavir (Kaletra) DRUG

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Also known as: ABT-378/r, Kaletra, Lopinavir/Ritonavir

non-B; pre-treated; therapy-naive

Eligibility Criteria

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

Study Population

Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abbott: lead

Study Sites (90)

Site Ref # / Investigator 27706

Aachen, 52062, Germany

Location

Site Ref # / Investigator 52972

Aachen, 52062, Germany

Location

Site Ref # / Investigator 27660

Berlin, 10117, Germany

Location

Site Ref # / Investigator 27937

Berlin, 10117, Germany

Location

Site Ref # / Investigator 52973

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 27629

Berlin, 10243, Germany

Location

Site Ref # / Investigator 27651

Berlin, 10439, Germany

Location

Site Ref # / Investigator 27912

Berlin, 10439, Germany

Location

Site Reference ID/Investigator# 27544

Berlin, 10439, Germany

Location

Site Reference ID/Investigator# 27567

Berlin, 10551, Germany

Location

Site Ref # / Investigator 27929

Berlin, 10589, Germany

Location

Site Ref # / Investigator 52971

Berlin, 10707, Germany

Location

Site Ref # / Investigator 53468

Berlin, 10707, Germany

Location

Site Ref # / Investigator 27965

Berlin, 10777, Germany

Location

Site Reference ID/Investigator# 27547

Berlin, 10777, Germany

Location

Site Reference ID/Investigator# 27552

Berlin, 10777, Germany

Location

Site Reference ID/Investigator# 27562

Berlin, 10777, Germany

Location

Site Ref # / Investigator 52984

Berlin, 10961, Germany

Location

Site Ref # / Investigator 27639

Berlin, 13347, Germany

Location

Site Ref # / Investigator 52970

Berlin, 13347, Germany

Location

Site Ref # / Investigator 27909

Berlin, D-10243, Germany

Location

Site Ref # / Investigator 47113

Berlin, D-10243, Germany

Location

Site Reference ID/Investigator# 27574

Chemnitz, 09113, Germany

Location

Site Ref # / Investigator 28060

Cologne, 50674, Germany

Location

Site Ref # / Investigator 52978

Cologne, 50674, Germany

Location

Site Ref # / Investigator 27932

Cologne, 50679, Germany

Location

Site Ref # / Investigator 52979

Cologne, 50679, Germany

Location

Site Ref # / Investigator 48233

Cologne, 50931, Germany

Location

Site Ref # / Investigator 52985

Cologne, 50931, Germany

Location

Site Ref # / Investigator 53464

Cologne, 50931, Germany

Location

Site Ref # / Investigator 27704

Dortmund, 44137, Germany

Location

Site Ref # / Investigator 27947

Dortmund, 44137, Germany

Location

Site Ref # / Investigator 52968

Dortmund, 44137, Germany

Location

Site Reference ID/Investigator# 27558

Duisburg, 47259, Germany

Location

Site Ref # / Investigator 28056

Düsseldorf, 40237, Germany

Location

Site Ref # / Investigator 52983

Frankfurt, 15232, Germany

Location

Site Ref # / Investigator 27928

Frankfurt, 60311, Germany

Location

Site Ref # / Investigator 52967

Frankfurt, 60311, Germany

Location

Site Reference ID/Investigator# 27565

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 27566

Fürth, 90762, Germany

Location

Site Ref # / Investigator 53465

Fürth, D-90762, Germany

Location

Site Ref # / Investigator 27931

Hamburg, 20099, Germany

Location

Site Ref # / Investigator 27982

Hamburg, 20099, Germany

Location

Site Ref # / Investigator 47114

Hamburg, 20099, Germany

Location

Site Ref # / Investigator 47115

Hamburg, 20099, Germany

Location

Site Reference ID/Investigator# 27551

Hamburg, 20099, Germany

Location

Site Reference ID/Investigator# 27634

Hamburg, 20099, Germany

Location

Site Ref # / Investigator 30864

Hamburg, 20146, Germany

Location

Site Ref # / Investigator 5348

Hamburg, 20146, Germany

Location

Site Reference ID/Investigator# 27546

Hamburg, 20146, Germany

Location

Site Ref # / Investigator 28032

Hamburg, 20246, Germany

Location

Site Ref # / Investigator 52969

Hamburg, 20246, Germany

Location

Site Ref # / Investigator 53467

Hamburg, 20246, Germany

Location

Site Ref # / Investigator 52980

Hamburg, 20354, Germany

Location

Site Ref # / Investigator 27641

Karlsruhe, 76135, Germany

Location

Site Ref # / Investigator 27964

Karlsruhe, 76135, Germany

Location

Site Reference ID/Investigator# 27561

Karlsruhe, 76135, Germany

Location

Site Ref # / Investigator 53466

Koblenz, 56065, Germany

Location

Site Reference ID/Investigator# 27555

Koblenz, 56065, Germany

Location

Site Ref # / Investigator 27905

Krefeld, 47800, Germany

Location

Site Ref # / Investigator 27906

Leipzig, 04107, Germany

Location

Site Ref # / Investigator 52975

Leipzig, 04107, Germany

Location

Site Ref # / Investigator 53463

Leipzig, 04107, Germany

Location

Site Ref # / Investigator 27948

Ludwigshafen, 67063, Germany

Location

Site Ref # / Investigator 52977

Ludwigshafen, 67063, Germany

Location

Site Ref # / Investigator 27902

Mainz, 55116, Germany

Location

Site Reference ID/Investigator# 27543

Mainz, 55116, Germany

Location

Site Ref # / Investigator 28104

Mönchengladbach, 41061, Germany

Location

Site Ref # / Investigator 52981

Mönchengladbach, 41061, Germany

Location

Site Ref # / Investigator 27949

Munich, 80337, Germany

Location

Site Reference ID/Investigator# 27553

Munich, 80337, Germany

Location

Site Ref # / Investigator 27926

Munich, 80801, Germany

Location

Site Ref # / Investigator 53462

Munich, 80801, Germany

Location

Site Ref # / Investigator 27648

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 27568

Münster, 48149, Germany

Location

Site Ref # / Investigator 52982

Nuremberg, 90419, Germany

Location

Site Ref # / Investigator 27988

Oldenburg, 26121, Germany

Location

Site Reference ID/Investigator# 27563

Oldenburg, 26121, Germany

Location

Site Ref # / Investigator 27637

Osnabrück, 49076, Germany

Location

Site Ref # / Investigator 27943

Osnabrück, 49076, Germany

Location

Site Ref # / Investigator 52974

Osnabrück, 49076, Germany

Location

Site Ref # / Investigator 27939

Paderborn, 33100, Germany

Location

Site Ref # / Investigator 27649

Rostock, 18057, Germany

Location

Site Reference ID/Investigator# 27569

Rostock, D-18057, Germany

Location

Site Ref # / Investigator 27647

Stuttgart, 70197, Germany

Location

Site Ref # / Investigator 28047

Stuttgart, 70197, Germany

Location

Site Ref # / Investigator 28048

Stuttgart, 70197, Germany

Location

Site Reference ID/Investigator# 27631

Stuttgart, 70197, Germany

Location

Site Ref # / Investigator 52976

Troisdorf, 53840, Germany

Location

Site Ref # / Investigator 27961

Wuppertal, 42277, Germany

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Interventions

Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Stefan Simianer, MD

  Abbott Germany, Medical Department

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 10, 2010
• Study Start: June 1, 2001
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 11, 2011
• Results First Posted: July 29, 2011

Record last verified: 2011-08

Locations

DE (90)