COMO: Cognition Study With HIV+ Patients (CTNPT 015)

Cognitive Symptoms Clinical Trial

— COMO  

Official title:

CTNPT 015 - Pilot Project to Implement a Step-wise Investigation That Includes Cerebrospinal (CSF) Analysis as a Standard of Care for HIV+ Individuals With Cognitive Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02144688
• Other study ID #: CTNPT 015
• Status: Terminated
• Phase: Phase 0
• First received: March 29, 2014
• Last updated: March 15, 2016
• Start date: June 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Public Health Agency of Canada
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT01848678

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• are 18 years and older

• have the capacity to give informed consent as determined by the research nurse

• have unexplained cognitive decline (reported either by the patient or an outside informant)

• have been on a stable ART regimen for > 6 months

• have an undetectable viral load in plasma for at least 6 months (a single blip of = 150 copies/mL will be accepted)

• have not had a change in medications that could potentially interfere with cognition in the past 4 months

Exclusion Criteria:

• detectable VL in the plasma

• past history of dementia

• past history of Central Nervous System opportunistic infection or stroke

• current substance abuse ( as per DSM-IV criteria) other than cigarettes

• coagulopathy

• thrombocytopenia

• use of Coumadin

• intra-cranial hypertension

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cognitive Symptoms
• HIV - Human Immunodeficiency Virus
• HIV Infections
• Immunologic Deficiency Syndromes
• Neurobehavioral Manifestations

Intervention

Drug:
• Change in antiretrovirals
Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis

Locations

Country	Name	City	State
Canada	Montreal Chest Institute - Chronic Viral Illness Service - McGill University Health Centre (MUHC)	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Marie-Josée Brouillette	CIHR Canadian HIV Trials Network, Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (30)

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. Epub 2007 Oct 3. — View Citation

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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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   CIHR Canadian HIV Trials Network