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In 14 participants who had LP, very low level viremia was found in only 1
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| Name | Class |
|---|---|
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
| CIHR Canadian HIV Trials Network | NETWORK |
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The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Change in ARVs to improve cognition | Experimental | Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in antiretrovirals | Drug | Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in neurocognitive functioning over 6 months | Cognition will be assessed at study entry and 6 months with the following tests: Letter Fluency, Category Fluency, Letter-Number Sequencing, Digit-Symbol, Symbol Search, Grooved Pegboard, Hopkins Verbal Learning Test-Revised, Stroop, Brief Visuospatial Memory Test-Revised, Tower of London, Trail Making Test A and B, Spatial Span, Montreal Cognitive Assessment (MoCA), and a brief computerized battery of tests (B-CAM). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Josée Brouillette, MD, FRCPC | Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC) | Montreal | Quebec | H2X 2P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17914061 | Background | Antinori A, Arendt G, Becker JT, Brew BJ, Byrd DA, Cherner M, Clifford DB, Cinque P, Epstein LG, Goodkin K, Gisslen M, Grant I, Heaton RK, Joseph J, Marder K, Marra CM, McArthur JC, Nunn M, Price RW, Pulliam L, Robertson KR, Sacktor N, Valcour V, Wojna VE. Updated research nosology for HIV-associated neurocognitive disorders. Neurology. 2007 Oct 30;69(18):1789-99. doi: 10.1212/01.WNL.0000287431.88658.8b. Epub 2007 Oct 3. | |
| 123519 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019954 | Neurobehavioral Manifestations |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D044966 | Anti-Retroviral Agents |
| ID | Term |
|---|---|
| D000998 | Antiviral Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| Background |
| Morrison NE, Collins FM. Immunogenicity of an aerogenic BCG vaccine in T-cell-depleted and normal mice. Infect Immun. 1975 May;11(5):1110-21. doi: 10.1128/iai.11.5.1110-1121.1975. |
| 15075493 | Background | Becker JT, Lopez OL, Dew MA, Aizenstein HJ. Prevalence of cognitive disorders differs as a function of age in HIV virus infection. AIDS. 2004 Jan 1;18 Suppl 1:S11-8. |
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| 12177366 | Background | De Luca A, Ciancio BC, Larussa D, Murri R, Cingolani A, Rizzo MG, Giancola ML, Ammassari A, Ortona L. Correlates of independent HIV-1 replication in the CNS and of its control by antiretrovirals. Neurology. 2002 Aug 13;59(3):342-7. doi: 10.1212/wnl.59.3.342. |
| 12056927 | Background | Ellis RJ, Moore DJ, Childers ME, Letendre S, McCutchan JA, Wolfson T, Spector SA, Hsia K, Heaton RK, Grant I. Progression to neuropsychological impairment in human immunodeficiency virus infection predicted by elevated cerebrospinal fluid levels of human immunodeficiency virus RNA. Arch Neurol. 2002 Jun;59(6):923-8. doi: 10.1001/archneur.59.6.923. |
| 18852864 | Background | Florkowski CM. Sensitivity, specificity, receiver-operating characteristic (ROC) curves and likelihood ratios: communicating the performance of diagnostic tests. Clin Biochem Rev. 2008 Aug;29 Suppl 1(Suppl 1):S83-7. |
| 19247836 | Background | Hardy DJ, Vance DE. The neuropsychology of HIV/AIDS in older adults. Neuropsychol Rev. 2009 Jun;19(2):263-72. doi: 10.1007/s11065-009-9087-0. Epub 2009 Feb 27. |
| 17502721 | Background | McCutchan JA, Wu JW, Robertson K, Koletar SL, Ellis RJ, Cohn S, Taylor M, Woods S, Heaton R, Currier J, Williams PL. HIV suppression by HAART preserves cognitive function in advanced, immune-reconstituted AIDS patients. AIDS. 2007 May 31;21(9):1109-17. doi: 10.1097/QAD.0b013e3280ef6acd. |
| 10883716 | Background | Jones RN, Gallo JJ. Dimensions of the Mini-Mental State Examination among community dwelling older adults. Psychol Med. 2000 May;30(3):605-18. doi: 10.1017/s0033291799001853. |
| 19307324 | Background | Koski L, Xie H, Finch L. Measuring cognition in a geriatric outpatient clinic: Rasch analysis of the Montreal Cognitive Assessment. J Geriatr Psychiatry Neurol. 2009 Sep;22(3):151-60. doi: 10.1177/0891988709332944. Epub 2009 Mar 23. |
| 18195140 | Background | Letendre S, Marquie-Beck J, Capparelli E, Best B, Clifford D, Collier AC, Gelman BB, McArthur JC, McCutchan JA, Morgello S, Simpson D, Grant I, Ellis RJ; CHARTER Group. Validation of the CNS Penetration-Effectiveness rank for quantifying antiretroviral penetration into the central nervous system. Arch Neurol. 2008 Jan;65(1):65-70. doi: 10.1001/archneurol.2007.31. |
| 15349869 | Background | Letendre SL, McCutchan JA, Childers ME, Woods SP, Lazzaretto D, Heaton RK, Grant I, Ellis RJ; HNRC Group. Enhancing antiretroviral therapy for human immunodeficiency virus cognitive disorders. Ann Neurol. 2004 Sep;56(3):416-23. doi: 10.1002/ana.20198. |
| 12707454 | Background | Marra CM, Lockhart D, Zunt JR, Perrin M, Coombs RW, Collier AC. Changes in CSF and plasma HIV-1 RNA and cognition after starting potent antiretroviral therapy. Neurology. 2003 Apr 22;60(8):1388-90. doi: 10.1212/01.wnl.0000058768.73358.1a. |
| 19424052 | Background | Marra CM, Zhao Y, Clifford DB, Letendre S, Evans S, Henry K, Ellis RJ, Rodriguez B, Coombs RW, Schifitto G, McArthur JC, Robertson K; AIDS Clinical Trials Group 736 Study Team. Impact of combination antiretroviral therapy on cerebrospinal fluid HIV RNA and neurocognitive performance. AIDS. 2009 Jul 17;23(11):1359-66. doi: 10.1097/QAD.0b013e32832c4152. |
| 16914973 | Background | Nath A, Sacktor N. Influence of highly active antiretroviral therapy on persistence of HIV in the central nervous system. Curr Opin Neurol. 2006 Aug;19(4):358-61. doi: 10.1097/01.wco.0000236614.51592.ca. |
| 1733335 | Background | Nilsson C, Stahlberg F, Thomsen C, Henriksen O, Herning M, Owman C. Circadian variation in human cerebrospinal fluid production measured by magnetic resonance imaging. Am J Physiol. 1992 Jan;262(1 Pt 2):R20-4. doi: 10.1152/ajpregu.1992.262.1.R20. |
| 11399956 | Background | Pilcher CD, Shugars DC, Fiscus SA, Miller WC, Menezes P, Giner J, Dean B, Robertson K, Hart CE, Lennox JL, Eron JJ Jr, Hicks CB. HIV in body fluids during primary HIV infection: implications for pathogenesis, treatment and public health. AIDS. 2001 May 4;15(7):837-45. doi: 10.1097/00002030-200105040-00004. |
| 10509569 | Background | Price RW, Yiannoutsos CT, Clifford DB, Zaborski L, Tselis A, Sidtis JJ, Cohen B, Hall CD, Erice A, Henry K. Neurological outcomes in late HIV infection: adverse impact of neurological impairment on survival and protective effect of antiviral therapy. AIDS Clinical Trial Group and Neurological AIDS Research Consortium study team. AIDS. 1999 Sep 10;13(13):1677-85. doi: 10.1097/00002030-199909100-00011. |
| 17721099 | Background | Robertson KR, Smurzynski M, Parsons TD, Wu K, Bosch RJ, Wu J, McArthur JC, Collier AC, Evans SR, Ellis RJ. The prevalence and incidence of neurocognitive impairment in the HAART era. AIDS. 2007 Sep 12;21(14):1915-21. doi: 10.1097/QAD.0b013e32828e4e27. |
| 15097298 | Background | Robertson KR, Robertson WT, Ford S, Watson D, Fiscus S, Harp AG, Hall CD. Highly active antiretroviral therapy improves neurocognitive functioning. J Acquir Immune Defic Syndr. 2004 May 1;36(1):562-6. doi: 10.1097/00126334-200405010-00003. |
| 17292021 | Background | Schultz-Larsen K, Kreiner S, Lomholt RK. Mini-Mental Status Examination: mixed Rasch model item analysis derived two different cognitive dimensions of the MMSE. J Clin Epidemiol. 2007 Mar;60(3):268-79. doi: 10.1016/j.jclinepi.2006.06.007. Epub 2006 Aug 10. |
| 15365130 | Background | Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7. doi: 10.1212/01.wnl.0000134665.58343.8d. |
| 16619159 | Background | Valcour V, Paul R. HIV infection and dementia in older adults. Clin Infect Dis. 2006 May 15;42(10):1449-54. doi: 10.1086/503565. Epub 2006 Apr 13. |
| 18580585 | Background | Wouters H, van Gool WA, Schmand B, Lindeboom R. Revising the ADAS-cog for a more accurate assessment of cognitive impairment. Alzheimer Dis Assoc Disord. 2008 Jul-Sep;22(3):236-44. doi: 10.1097/WAD.0b013e318174f8b9. |
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020164 |
| Chemical Actions and Uses |