Overview

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

Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marie-Josée Brouillette
Collaborators:
CIHR Canadian HIV Trials Network
Fonds de la Recherche en Santé du Québec
Treatments:
Anti-Retroviral Agents
Criteria
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