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The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZT+3TC+IDV+RTV | Drug | |||
| AZT+3TC+EFV | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months. | ||
| Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive | ||
| CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+) | ||
| and levels of CD8 cells (CD28+ y CD38+) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose M Gatell, MD | Hospital Clinic of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | 08025 | Spain | ||
| Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20624069 | Derived | Miro JM, Manzardo C, Pich J, Domingo P, Ferrer E, Arribas JR, Ribera E, Arrizabalaga J, Lonca M, Cruceta A, de Lazzari E, Fuster M, Podzamczer D, Plana M, Gatell JM; Advanz Study Group. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010 Jul;26(7):747-57. doi: 10.1089/aid.2009.0105. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Incidence of adverse events |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| CSU Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Donostia Ospitaleak | Donostia / San Sebastian | Giputzkoa | 20014 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| 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 |