Evaluation of Kaletra Therapy Over the Long-term

Human Immunodeficiency Virus Clinical Trial

Official title:

Evaluation of Kaletra Therapy Over the Long-term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083810
• Other study ID #: KAL 1 RO
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: August 9, 2011
• Start date: June 2001
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Long term observation of patients under lopinavir/ritonavir containing therapy

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.

Other known NCT identifiers

• NCT01081470
• NCT01083836

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Locations

Country	Name	City	State
Germany	Site Ref # / Investigator 27706	Aachen
Germany	Site Ref # / Investigator 52972	Aachen
Germany	Site Ref # / Investigator 27639	Berlin
Germany	Site Ref # / Investigator 27651	Berlin
Germany	Site Ref # / Investigator 27660	Berlin
Germany	Site Ref # / Investigator 27909	Berlin
Germany	Site Ref # / Investigator 27912	Berlin
Germany	Site Ref # / Investigator 27929	Berlin
Germany	Site Ref # / Investigator 27937	Berlin
Germany	Site Ref # / Investigator 27965	Berlin
Germany	Site Ref # / Investigator 47113	Berlin
Germany	Site Ref # / Investigator 52970	Berlin
Germany	Site Ref # / Investigator 52971	Berlin
Germany	Site Ref # / Investigator 52973	Berlin
Germany	Site Ref # / Investigator 52984	Berlin
Germany	Site Ref # / Investigator 53468	Berlin
Germany	Site Reference ID/Investigator# 27544	Berlin
Germany	Site Reference ID/Investigator# 27547	Berlin
Germany	Site Reference ID/Investigator# 27552	Berlin
Germany	Site Reference ID/Investigator# 27562	Berlin
Germany	Site Reference ID/Investigator# 27567	Berlin
Germany	Site Reference ID/Investigator# 27629	Berlin
Germany	Site Reference ID/Investigator# 27574	Chemnitz
Germany	Site Ref # / Investigator 27932	Cologne
Germany	Site Ref # / Investigator 28060	Cologne
Germany	Site Ref # / Investigator 48233	Cologne
Germany	Site Ref # / Investigator 52978	Cologne
Germany	Site Ref # / Investigator 52979	Cologne
Germany	Site Ref # / Investigator 52985	Cologne
Germany	Site Ref # / Investigator 53464	Cologne
Germany	Site Ref # / Investigator 27704	Dortmund
Germany	Site Ref # / Investigator 27947	Dortmund
Germany	Site Ref # / Investigator 52968	Dortmund
Germany	Site Ref # / Investigator 28056	Duesseldorf
Germany	Site Reference ID/Investigator# 27558	Duisburg
Germany	Site Ref # / Investigator 27928	Frankfurt
Germany	Site Ref # / Investigator 52967	Frankfurt
Germany	Site Ref # / Investigator 52983	Frankfurt
Germany	Site Reference ID/Investigator# 27565	Freiburg
Germany	Site Ref # / Investigator 53465	Fuerth
Germany	Site Reference ID/Investigator# 27566	Fuerth
Germany	Site Ref # / Investigator 27931	Hamburg
Germany	Site Ref # / Investigator 27982	Hamburg
Germany	Site Ref # / Investigator 28032	Hamburg
Germany	Site Ref # / Investigator 30864	Hamburg
Germany	Site Ref # / Investigator 47114	Hamburg
Germany	Site Ref # / Investigator 47115	Hamburg
Germany	Site Ref # / Investigator 52969	Hamburg
Germany	Site Ref # / Investigator 52980	Hamburg
Germany	Site Ref # / Investigator 53467	Hamburg
Germany	Site Ref # / Investigator 5348	Hamburg
Germany	Site Reference ID/Investigator# 27546	Hamburg
Germany	Site Reference ID/Investigator# 27551	Hamburg
Germany	Site Reference ID/Investigator# 27634	Hamburg
Germany	Site Ref # / Investigator 27641	Karlsruhe
Germany	Site Ref # / Investigator 27964	Karlsruhe
Germany	Site Reference ID/Investigator# 27561	Karlsruhe
Germany	Site Ref # / Investigator 53466	Koblenz
Germany	Site Reference ID/Investigator# 27555	Koblenz
Germany	Site Ref # / Investigator 27905	Krefeld
Germany	Site Ref # / Investigator 27906	Leipzig
Germany	Site Ref # / Investigator 52975	Leipzig
Germany	Site Ref # / Investigator 53463	Leipzig
Germany	Site Ref # / Investigator 27948	Ludwigshafen
Germany	Site Ref # / Investigator 52977	Ludwigshafen
Germany	Site Ref # / Investigator 27902	Mainz
Germany	Site Reference ID/Investigator# 27543	Mainz
Germany	Site Ref # / Investigator 28104	Moenchengladbach
Germany	Site Ref # / Investigator 52981	Moenchengladbach
Germany	Site Ref # / Investigator 27648	Muenster
Germany	Site Reference ID/Investigator# 27568	Muenster
Germany	Site Ref # / Investigator 27926	Munich
Germany	Site Ref # / Investigator 27949	Munich
Germany	Site Ref # / Investigator 53462	Munich
Germany	Site Reference ID/Investigator# 27553	Munich
Germany	Site Ref # / Investigator 52982	Nuernberg
Germany	Site Ref # / Investigator 27988	Oldenburg
Germany	Site Reference ID/Investigator# 27563	Oldenburg
Germany	Site Ref # / Investigator 27637	Osnabrueck
Germany	Site Ref # / Investigator 27943	Osnabrueck
Germany	Site Ref # / Investigator 52974	Osnabrueck
Germany	Site Ref # / Investigator 27939	Paderborn
Germany	Site Ref # / Investigator 27649	Rostock
Germany	Site Reference ID/Investigator# 27569	Rostock
Germany	Site Ref # / Investigator 27647	Stuttgart
Germany	Site Ref # / Investigator 28047	Stuttgart
Germany	Site Ref # / Investigator 28048	Stuttgart
Germany	Site Reference ID/Investigator# 27631	Stuttgart
Germany	Site Ref # / Investigator 52976	Troisdorf
Germany	Site Ref # / Investigator 27961	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Patients With HIV-1 RNA <50 Copies/ml	All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks	No
Secondary	Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml	All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks	No
Secondary	Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml	All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks	No
Secondary	Percentage of Patients With HIV-1 RNA >500 Copies/ml	All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks	No
Secondary	Change in Absolute CD4 Cell Count [CD4+ Cells/µL]	The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks	No