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| ID | Type | Description | Link |
|---|---|---|---|
| TMC114HIV0010 | Other Identifier | Janssen-Cilag S.p.A., Italy |
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The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active antiretroviral therapy (HAART) regimen.
This is an ex-vivo study (study which takes place outside the organism and records immune parameters from stored blood and cells of a defined population without any intervention by the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and DRV/r compared with EFV in recovering T-lymphocyte function (functional immunity) will be studied. Blood samples will be analyzed before (baseline) and up to 48 weeks after initiating HAART.
Each patient will receive orally administered (given by mouth) regimens of either Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) + Tenofovir/Emtricitabina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir/Ritonavir (DRV/r) |
| ||
| Efavirenz (EFV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir/Ritonavir (DRV/r) | Drug | Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells | Baseline, Week 12, and Week 48 | |
| Change in peripheral T-lymphocyte immune phenotype | Baseline, Week 12, Week 24 and Week 48 |
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Inclusion Criteria:
Exclusion Criteria is not defined in protocol.
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Antiretroviral treatment-naive patients with advanced HIV infection starting a Darunavir/Ritonavir - or Efavirenz-based HAART regimen. Patients with advanced HIV infection are defined by a treatment-naïve CD4+ cell count >50 to <250 cells/mm3.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag S.p.A., Italy Clinical Trial | Janssen-Cilag S.p.A. | Study Director |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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| Efavirenz (EFV) | Drug | Efavirenz (EFV) + Tenofovir/Emtricitabina regimen |
|
| Change in peripheral T-lymphocyte turnover | Baseline, Week 12, Week 24 and Week 48 |
| 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 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |