Clinical trial NCT04138199: 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
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV-1 Infection
Keywords: Lopinavir/ritonavir (LPV/r)
Kaletra
Human Immunodeficiency Virus (HIV)
Generic Product
Highly Active Anti-Retroviral Therapy (HAART)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Human Immunodeficiency Virus Type-1 (HIV-1) infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3
timeFrame: Up to 48 Weeks
measure: Indicator of Participants Who Have a Development of New or Recurrent Opportunistic Infections or HIV-Associated Malignancies OR any SAE Associated With HIV Treatment
timeFrame: From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment
Secondary outcomes:
measure: Time to Failure
timeFrame: Up to Week 48
measure: Change in HIV-1- RNA Viral Load Compared To The Last Measure On Kaletra Treatment
timeFrame: Up to Week 48
measure: Change in CD4+ T-cell Counts Compared To The Last Measure On Kaletra Treatment
timeFrame: Up to Week 48
measure: 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
timeFrame: Up to Week 48
measure: Percentage of Participants Who Develop HIV Drug Resistance Of Generic LPV/r Treatment
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Rep. Cen. of AIDS Profilactis /ID# 216292
state: Tatarstan, Respublika
city: Cheboksary
country: Russian Federation
facility: Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479
city: Chelyabinsk
country: Russian Federation
facility: Reg Ctr for AIDS /ID# 216288
city: Ekaterinburg
country: Russian Federation
facility: GBUZ Regional Center for the P /ID# 216293
city: Krasnoyarsk
country: Russian Federation
facility: Reg Ctr for AIDS /ID# 216295
city: Rostov on Don
country: Russian Federation
facility: Ctr for AIDS Rostov /ID# 216289
city: Samara
country: Russian Federation
facility: Samara region HIV/AIDS Center /ID# 216290
city: Saransk
country: Russian Federation
facility: Mordovian Republican Center for the Prevention and Control of AIDS /ID# 216480
city: Saratov
country: Russian Federation
facility: Saratov Regional Center for the Prevention and Control of AIDS /ID# 216291
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: GBUZ Sakhalin Regional Center for the Prevention and Control of AIDS /ID# 216478
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: