A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation (COPI)

Multi-Center Observational Study to Assess Effectiveness and Safety of Fixed Dose Combination of Generic Product of Lopinavir/Ritonavir in HIV-1 Infected Patients After Switching From Kaletra® (Lopinavir/Ritonavir) for Administrative Reasons in the Routine Clinical Settings of Russian Federation (COPI)

This is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of Lopinavir/Ritonavir (LPV/r) after switching from Kaletra in the routine clinical settings of Russian Federation.

Study Overview

• Status: Terminated
• Conditions: HIV-1 Infection

• Study Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• Russian Federation
  • Cheboksary, Russian Federation, 428003
    • Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479
  • Chelyabinsk, Russian Federation, 454052
    • Reg Ctr for AIDS /ID# 216288
  • Ekaterinburg, Russian Federation, 620102
    • GBUZ Regional Center for the P /ID# 216293
  • Krasnoyarsk, Russian Federation, 660049
    • Reg Ctr for AIDS /ID# 216295
  • Rostov on Don, Russian Federation, 344006
    • Ctr for AIDS Rostov /ID# 216289
  • Samara, Russian Federation, 443029
    • Samara region HIV/AIDS Center /ID# 216290
  • Saransk, Russian Federation, 430019
    • Mordovian Republican Center for the Prevention and Control of AIDS /ID# 216480
  • Saratov, Russian Federation, 410009
    • Saratov Regional Center for the Prevention and Control of AIDS /ID# 216291
  • Yuzhno-Sakhalinsk, Russian Federation, 693000
    • GBUZ Sakhalin Regional Center for the Prevention and Control of AIDS /ID# 216478
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420097
      • Rep. Cen. of AIDS Profilactis /ID# 216292

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with Human Immunodeficiency Virus Type-1 (HIV-1) infection

Description

Inclusion Criteria:

• Human Immunodeficiency Virus Type-1 (HIV-1) infected patients on any dual or triple Highly Active Anti-Retroviral Therapy (HAART) with Kaletra under observation at least 48 weeks and with two consequent plasma HIV-1 RNA levels within the last 24 weeks (plasma HIV-1 RNA level <50 copies/mL) switched to a generic LPV/r as decided by the physician in the routine clinical settings within last 24 weeks from study enrollment date.
• HIV-1 infected patients with last available CD4+ T-cell count test result > 200 cells/mm3 before switching from Kaletra.
• Other (not LPV/r) HAART medicine components of dual or triple HIV therapy not planned to change by regular physician after switching to generic LPV/r.
• Signed Inform Consent form by patient.

Exclusion Criteria:

• Participant has contraindications for the treatment with LPV/r.
• Legal or physical incapability of patient to sign Inform Consent form

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with Human Immunodeficiency Virus-1 Infection; Human Immunodeficiency Virus-1 (HIV-1) infected and clinically stable patients on dual or triple HAART including Kaletra who switched or planned to switch to generic product of lopinavir/ritonavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3	Percentage of participants who meet at least one of the following composite endpoint criteria : HIV-1- Ribonucleic Acid (RNA) viral load >50 copies/mL, OR Cluster of differentiation 4 (CD4+) T-cell counts < 200 cells/mm3.	Up to 48 Weeks
Indicator of Participants Who Have a Development of New or Recurrent Opportunistic Infections or HIV-Associated Malignancies OR any SAE Associated With HIV Treatment	Percentage of participants who meet at least one of the following composite endpoint criteria: Development of new or recurrent opportunistic infections or HIV-associated malignancies (based on physician observation and decision), OR Any Serious Adverse Event (SAE), associated with HIV treatment.	From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Failure	Percentage of participants who meet at least one of the following composite endpoint criteria: HIV-1- RNA viral load >50 copies/ml, OR CD4+ T-cell counts < 200 cells/mm3, OR development of new or recurrent opportunistic infections or HIV-associated malignancies (based on physician observation and decision), OR any Serious Adverse Event (SAE), associated with HIV treatment.	Up to Week 48
Change in HIV-1- RNA Viral Load Compared To The Last Measure On Kaletra Treatment	Untransformed (Absolute) and Base-10 Logarithm Transformed Data Values of HIV-1- RNA Viral Load and The Change As Compared To The Last Measure On Kaletra Treatment	Up to Week 48
Change in CD4+ T-cell Counts Compared To The Last Measure On Kaletra Treatment	Absolute values of CD4+ T-cell counts the change as compared to the last measure on Kaletra treatment will be summarized with descriptive statistics.	Up to Week 48
Percentage of Participants With Reasons For Switching From Generic LPV/r To Other Antiretroviral Therapy (ART) For HIV Therapy OR Change In The Dosing Regimen	Percentage of participants with different reasons for switching from generic LPV/r to other products of Antiretroviral Therapy (ART) for HIV therapy or change in the dosing regimen - medical reason (infectiveness, intolerance/toxicity, other), non-medical reasons (lack of availability of generic LPV/r, other) and other reasons.	Up to Week 48
Percentage of Participants Who Develop HIV Drug Resistance Of Generic LPV/r Treatment	Percentage of participants who develop resistance to each drug will be presented.	Up to Week 48

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): July 8, 2020
• Study Completion (ACTUAL): July 8, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (ACTUAL): October 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Kaletra; Human Immunodeficiency Virus (HIV); Lopinavir/ritonavir (LPV/r); Generic Product; Highly Active Anti-Retroviral Therapy (HAART)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: P20-097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No