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Strategic Considerations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Human Immunodeficiency Virus Type-1 (HIV-1) infection
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rep. Cen. of AIDS Profilactis /ID# 216292 | Kazan' | Tatarstan, Respublika | 420097 | Russia | ||
| Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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| 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 |
| 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 |
| 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 |
| 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 |
| Cheboksary |
| 428003 |
| Russia |
| Reg Ctr for AIDS /ID# 216288 | Chelyabinsk | 454052 | Russia |
| Reg Ctr for AIDS /ID# 216295 | Krasnoyarsk | 660049 | Russia |
| Ctr for AIDS Rostov /ID# 216289 | Rostov-on-Don | 344006 | Russia |
| Samara region HIV/AIDS Center /ID# 216290 | Samara | 443029 | Russia |
| Mordovian Republican Center for the Prevention and Control of AIDS /ID# 216480 | Saransk | 430019 | Russia |
| Saratov Regional Center for the Prevention and Control of AIDS /ID# 216291 | Saratov | 410009 | Russia |
| GBUZ Regional Center for the P /ID# 216293 | Yekaterinburg | 620102 | Russia |
| GBUZ Sakhalin Regional Center for the Prevention and Control of AIDS /ID# 216478 | Yuzhno-Sakhalinsk | 693000 | Russia |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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