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

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

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.

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