Kaletra: Therapy With Double Protease Inhibitors

NCT01075191 | Completed Results

• 1 other identifier: P05-103
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Human Immunodeficiency Virus

Keywords

Viral load; Resistance; Double protease inhibitors; Mutations; Immune system; Infection; Nucleoside Reverse Transcriptase Inhibitors-free; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL

  Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Secondary Outcomes (5)

• Change From Baseline in Absolute CD4 Cell Count

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Change From Baseline in Relative CD4 Cell Count

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Change From Baseline in Absolute CD8 Cell Count

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Change From Baseline in Relative CD8 Cell Count

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Change From Baseline in CD4/CD8 T-cell Ratio

  Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Study Arms (1)

HIV-infected participants

HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).

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

Community sample; Human Immunodeficiency Virus-infected participants

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (17)

Site Reference ID/Investigator# 48283

Berlin, 10439, Germany

Location

Site Reference ID/Investigator# 28131

Berlin, 10551, Germany

Location

Site Reference ID/Investigator# 66422

Berlin, 10961, Germany

Location

Site Reference ID/Investigator# 28123

Berlin, 13347, Germany

Location

Site Reference ID/Investigator# 28109

Berlin, D-10243, Germany

Location

Site Reference ID/Investigator# 28115

Dortmund, 44137, Germany

Location

Site Reference ID/Investigator# 28124

Frankfurt, 60311, Germany

Location

Site Reference ID/Investigator# 28127

Frankfurt, 60329, Germany

Location

Site Reference ID/Investigator# 28119

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 5318

Krefeld, 47800, Germany

Location

Site Reference ID/Investigator# 28112

Ludwigshafen, 67063, Germany

Location

Site Reference ID/Investigator# 28118

Munich, 80337, Germany

Location

Site Reference ID/Investigator# 28113

Munich, 80801, Germany

Location

Site Reference ID/Investigator# 28111

Münster, 48143, Germany

Location

Site Reference ID/Investigator# 28129

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 28133

Stuttgart, 70197, Germany

Location

Site Reference ID/Investigator# 28126

Wuppertal, 42277, Germany

Location

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

• Stefan Simianer, 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 23, 2010
• First Posted: February 25, 2010
• Study Start: January 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: October 30, 2012

Record last verified: 2013-01

Locations

DE (17)