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| ID | Type | Description | Link |
|---|---|---|---|
| Merck Sharp & Dohme Corp. | Other Identifier | Merck Sharp & Dohme Corp. |
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| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to correlate the different patterns of resistance mutations observed in vivo in patients failing RAL treatment with the fold-change resistance determined by the phenotypic assay.
The secondary objectives are, as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAL Group | HIV-1 infected patients failing to a RALTEGRAVIR-containing regimen |
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| Measure | Description | Time Frame |
|---|---|---|
| - mean value of fold-change resistance determined by the phenotypic assay at baseline | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| changes of fold-change resistance determined by the phenotypic assay with respect to baseline. | 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation | |
| genetic changes under continuous drug pressure or drug discontinuation with respect to baseline(dynamics of the reversion of resistance mutations) |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonella Castagna, MD | Contact | 0039022643 | 7934 | castagna.antonella@hsr.it |
| Elisabetta Carini, Msc | Contact | 0039022643 | 7934 | carini.elisabetta@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Clementi, Prof. | University Vita-Salute San Raffaele Laboratory of Microbiology and Virology | Principal Investigator |
| Antonella Castagna, MD | Department of Infectious Diseases, IRCCS San Raffaele Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, IRCCS San Raffaele Hospital | Recruiting | Milan | 20127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1760846 | Background | Engelman A, Mizuuchi K, Craigie R. HIV-1 DNA integration: mechanism of viral DNA cleavage and DNA strand transfer. Cell. 1991 Dec 20;67(6):1211-21. doi: 10.1016/0092-8674(91)90297-c. | |
| 15729361 | Background | Pommier Y, Johnson AA, Marchand C. Integrase inhibitors to treat HIV/AIDS. Nat Rev Drug Discov. 2005 Mar;4(3):236-48. doi: 10.1038/nrd1660. |
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whole blood
| 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation. |
| changes of the replication capacity with respect to baseline | 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation. |
| changes of HIV-RNA with respect to baseline | 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation |
| changes in CD4, CD4%, CD8, CD8% with respect to baseline | 24 and 48 hours, W1, W2, W3 and W4 upon discontinuation |
| 18095922 | Background | Anker M, Corales RB. Raltegravir (MK-0518): a novel integrase inhibitor for the treatment of HIV infection. Expert Opin Investig Drugs. 2008 Jan;17(1):97-103. doi: 10.1517/13543784.17.1.97. |
| 17434401 | Background | Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2. |
| 18650513 | Background | Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978. |
| 19165083 | Background | Canducci F, Sampaolo M, Marinozzi MC, Boeri E, Spagnuolo V, Galli A, Castagna A, Lazzarin A, Clementi M, Gianotti N. Dynamic patterns of human immunodeficiency virus type 1 integrase gene evolution in patients failing raltegravir-based salvage therapies. AIDS. 2009 Feb 20;23(4):455-60. doi: 10.1097/QAD.0b013e328323da60. |
| 19027039 | Background | Nakahara K, Wakasa-Morimoto C, Kobayashi M, Miki S, Noshi T, Seki T, Kanamori-Koyama M, Kawauchi S, Suyama A, Fujishita T, Yoshinaga T, Garvey EP, Johns BA, Foster SA, Underwood MR, Sato A, Fujiwara T. Secondary mutations in viruses resistant to HIV-1 integrase inhibitors that restore viral infectivity and replication kinetics. Antiviral Res. 2009 Feb;81(2):141-6. doi: 10.1016/j.antiviral.2008.10.007. Epub 2008 Nov 21. |
| 18625269 | Background | Kobayashi M, Nakahara K, Seki T, Miki S, Kawauchi S, Suyama A, Wakasa-Morimoto C, Kodama M, Endoh T, Oosugi E, Matsushita Y, Murai H, Fujishita T, Yoshinaga T, Garvey E, Foster S, Underwood M, Johns B, Sato A, Fujiwara T. Selection of diverse and clinically relevant integrase inhibitor-resistant human immunodeficiency virus type 1 mutants. Antiviral Res. 2008 Nov;80(2):213-22. doi: 10.1016/j.antiviral.2008.06.012. Epub 2008 Jul 14. |
| 19290031 | Background | Ceccherini-Silberstein F, Malet I, D'Arrigo R, Antinori A, Marcelin AG, Perno CF. Characterization and structural analysis of HIV-1 integrase conservation. AIDS Rev. 2009 Jan-Mar;11(1):17-29. |
| 18227187 | Background | Malet I, Delelis O, Valantin MA, Montes B, Soulie C, Wirden M, Tchertanov L, Peytavin G, Reynes J, Mouscadet JF, Katlama C, Calvez V, Marcelin AG. Mutations associated with failure of raltegravir treatment affect integrase sensitivity to the inhibitor in vitro. Antimicrob Agents Chemother. 2008 Apr;52(4):1351-8. doi: 10.1128/AAC.01228-07. Epub 2008 Jan 28. |
| 12646788 | Background | Menzo S, Monachetti A, Balotta C, Corvasce S, Rusconi S, Paolucci S, Baldanti F, Bagnarelli P, Clementi M. Processivity and drug-dependence of HIV-1 protease: determinants of viral fitness in variants resistant to protease inhibitors. AIDS. 2003 Mar 28;17(5):663-71. doi: 10.1097/01.aids.0000050852.71999.5f. |
| 19447792 | Background | Sichtig N, Sierra S, Kaiser R, Daumer M, Reuter S, Schulter E, Altmann A, Fatkenheuer G, Dittmer U, Pfister H, Esser S. Evolution of raltegravir resistance during therapy. J Antimicrob Chemother. 2009 Jul;64(1):25-32. doi: 10.1093/jac/dkp153. Epub 2009 May 14. |
| 19221102 | Background | Malet I, Delelis O, Soulie C, Wirden M, Tchertanov L, Mottaz P, Peytavin G, Katlama C, Mouscadet JF, Calvez V, Marcelin AG. Quasispecies variant dynamics during emergence of resistance to raltegravir in HIV-1-infected patients. J Antimicrob Chemother. 2009 Apr;63(4):795-804. doi: 10.1093/jac/dkp014. Epub 2009 Feb 16. |