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

Terminated

• Conditions: HIV-1 Infection

• Registration Number: NCT04138199
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-11-01
• Primary Completion: 2020-07-08
• Study Completion: 2020-07-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 239

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.
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.
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.

Trial Locations

Locations (10)

GBUZ Regional Center for the P /ID# 216293; 🇷🇺 Ekaterinburg, Russian Federation

Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479; 🇷🇺 Cheboksary, Russian Federation

Reg Ctr for AIDS /ID# 216288; 🇷🇺 Chelyabinsk, Russian Federation

Reg Ctr for AIDS /ID# 216295; 🇷🇺 Krasnoyarsk, Russian Federation

Rep. Cen. of AIDS Profilactis /ID# 216292; 🇷🇺 Kazan, Tatarstan, Respublika, Russian Federation

Ctr for AIDS Rostov /ID# 216289; 🇷🇺 Rostov on Don, Russian Federation

Samara region HIV/AIDS Center /ID# 216290; 🇷🇺 Samara, Russian Federation

Mordovian Republican Center for the Prevention and Control of AIDS /ID# 216480; 🇷🇺 Saransk, Russian Federation

Saratov Regional Center for the Prevention and Control of AIDS /ID# 216291; 🇷🇺 Saratov, Russian Federation

GBUZ Sakhalin Regional Center for the Prevention and Control of AIDS /ID# 216478; 🇷🇺 Yuzhno-Sakhalinsk, Russian Federation