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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04138199
Other study ID # P20-097
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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