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

Marie-Josée Brouillette

Status and phase: Terminated; Early Phase 1

Conditions: Cognitive Symptoms; HIV - Human Immunodeficiency Virus

Treatments: Drug: Change in antiretrovirals

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02144688

CTNPT 015

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Change in ARVs to improve cognition

Experimental group

Description:

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

Treatment:

Drug: Change in antiretrovirals