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

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)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04138199

Acronym

COPI

Enrollment

239

Registered

2019-10-24

Start date

2019-11-01

Completion date

2020-07-08

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Keywords

Lopinavir/ritonavir (LPV/r), Kaletra, Human Immunodeficiency Virus (HIV), Generic Product, Highly Active Anti-Retroviral Therapy (HAART)

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3	Up to 48 Weeks	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.
Indicator of Participants Who Have a Development of New or Recurrent Opportunistic Infections or HIV-Associated Malignancies OR any SAE Associated With HIV Treatment	From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment	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.

Secondary

Measure	Time frame	Description
Change in CD4+ T-cell Counts Compared To The Last Measure On Kaletra Treatment	Up to Week 48	Absolute values of CD4+ T-cell counts the change as compared to the last measure on Kaletra treatment will be summarized with descriptive statistics.
Time to Failure	Up to Week 48	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.
Percentage of Participants Who Develop HIV Drug Resistance Of Generic LPV/r Treatment	Up to Week 48	Percentage of participants who develop resistance to each drug will be presented.
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	Up to Week 48	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.
Change in HIV-1- RNA Viral Load Compared To The Last Measure On Kaletra Treatment	Up to Week 48	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

Countries

Russia

Outcome results