COPI: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with Human Immunodeficiency Virus-1 Infection Human Immunodeficiency Virus-1 (HIV-1) infected and clinically stable patients on dual or triple HAART including Kaletra who switched or planned to switch to generic product of lopinavir/ritonavir |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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HIV-1 infected patients with last available CD4+ T-cell count test result > 200 cells/mm3 before switching from Kaletra.
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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.
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Signed Inform Consent form by patient.
Exclusion Criteria:
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Participant has contraindications for the treatment with LPV/r.
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Legal or physical incapability of patient to sign Inform Consent form
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rep. Cen. of AIDS Profilactis /ID# 216292 | Kazan | Tatarstan, Respublika | Russian Federation | 420097 |
| 2 | Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479 | Cheboksary | Russian Federation | 428003 | |
| 3 | Reg Ctr for AIDS /ID# 216288 | Chelyabinsk | Russian Federation | 454052 | |
| 4 | GBUZ Regional Center for the P /ID# 216293 | Ekaterinburg | Russian Federation | 620102 | |
| 5 | Reg Ctr for AIDS /ID# 216295 | Krasnoyarsk | Russian Federation | 660049 | |
| 6 | Ctr for AIDS Rostov /ID# 216289 | Rostov on Don | Russian Federation | 344006 | |
| 7 | Samara region HIV/AIDS Center /ID# 216290 | Samara | Russian Federation | 443029 | |
| 8 | Mordovian Republican Center for the Prevention and Control of AIDS /ID# 216480 | Saransk | Russian Federation | 430019 | |
| 9 | Saratov Regional Center for the Prevention and Control of AIDS /ID# 216291 | Saratov | Russian Federation | 410009 | |
| 10 | GBUZ Sakhalin Regional Center for the Prevention and Control of AIDS /ID# 216478 | Yuzhno-Sakhalinsk | Russian Federation | 693000 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P20-097