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

HIV-1 Infection Clinical Trial

— COPI  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04138199
• Other study ID #: P20-097
• Status: Terminated
• Start date: November 1, 2019
• Est. completion date: July 8, 2020

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 239
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-1 Infection

Locations

Country	Name	City	State
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	GBUZ Regional Center for the P /ID# 216293	Ekaterinburg
Russian Federation	Rep. Cen. of AIDS Profilactis /ID# 216292	Kazan	Tatarstan, Respublika
Russian Federation	Reg Ctr for AIDS /ID# 216295	Krasnoyarsk
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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis