Overview

Clinical Trial of CNS-targeted HAART (CIT2)

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Treatments:
Abacavir
Amprenavir
Anti-Retroviral Agents
Atazanavir Sulfate
Darunavir
Delavirdine
Efavirenz
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Enfuvirtide
Etravirine
Fosamprenavir
Lamivudine
Lamivudine, zidovudine drug combination
Lopinavir
Maraviroc
Nelfinavir
Nevirapine
Raltegravir Potassium
Ritonavir
Saquinavir
Tenofovir
Tipranavir
Zidovudine