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The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV + | Active Comparator |
| |
| HCV - | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Drug | 400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Changes in liver functions enzyme. | Baseline, Week 4, Week 8, Week 16 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures | Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load | Baseline, Week 4, Week 8, Week 16 and Week 24 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos R Rivera-Vazquez, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 4118 | Bayamón | 00960 | Puerto Rico | |||
| Site Reference ID/Investigator# 4119 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Bayamón |
| 00961 |
| Puerto Rico |
| Site Reference ID/Investigator# 6298 | Juana Diaz | 00795 | Puerto Rico |
| Site Reference ID/Investigator# 6284 | Las Piedras | 00771 | Puerto Rico |
| Site Reference ID/Investigator# 4101 | Mayagüez | 00680 | Puerto Rico |
| Site Reference ID/Investigator# 4116 | Playa de Ponce | 00731 | Puerto Rico |
| Site Reference ID/Investigator# 4117 | Ponce | 00717-1563 | Puerto Rico |
| Site Reference ID/Investigator# 4099 | Ponce | 00731 | Puerto Rico |
| Site Reference ID/Investigator# 4086 | Rio Piedras | 00926 | Puerto Rico |
| Site Reference ID/Investigator# 4080 | San Juan | 00908 | Puerto Rico |
| Site Reference ID/Investigator# 4100 | Santurce | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| 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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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