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A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAL QD 800 mg/24 hs | Experimental |
| |
| RAL BID 400 mg/12 hs | Active Comparator |
| |
| RAL BID to QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir (Use RAL as a simplification strategy) | Drug | RAL QD: RAL 800 mg/24 hs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 gains, lipid profile, adverse events, | 24 weeks | |
| Drug resistance mutations | 24 weeks | |
| Raltegravir through plasma levels and correlation with virological failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Soriano, Dr | Hospital Carlos III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Carlos III | Recruiting | Madrid | Madrid | 28029 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20974575 | Derived | Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204. doi: 10.1310/hct1104-197. |
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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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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Raltegravir (Use RAL as a simplification strategy) |
| Drug |
RAL BID 400 mg/12 hs |
|
| Raltegravir (Use RAL as a simplification strategy) | Drug | RAL BID to QD |
|
| 24 weeks |
| 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 |