Clinical Trial of CNS-targeted HAART (CIT2)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• HIV infected- confirmed by ELISA or 2 prior viral loads >2000

• 18 years or older

• Under consideration to initiate or change their HAART regimens (based on current consensus treatment guidelines) as directed by their primary care physicians.

• Measurable HIV Neurocognitive Impairment (HNCI)

• Willing and able to undergo at least 3 lumbar punctures safely during the course of the study.

• Potential subjects must have a Karnofsky score of > or = to 60 within 60 days prior to study entry.

• Potential subjects must have a CD4 cell count obtained within 60 days prior to study entry.

Exclusion Criteria:

• Presence of serious illness, including HIV-related opportunistic infections, requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.

• Presence of neurologic disorders other than HIV judged to be the principal cause of neurocognitive impairment.

• Presence of active, severe psychiatric disorders (e.g., major depression, schizophrenia) that would interfere with interpretation of the study evaluations or adherence to the study protocol or that might make their participation in the study problematic or unsafe.

• Presence of active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

• Use of any immunomodulator (interferons, interleukins, cyclosporine), vaccine, or investigational therapy including dexamethasone within 30 days prior to study entry.

• Inability to provide informed consent.

• Enrollment in other ARV treatment studies, unless the study is: 1) observational; 2) a compassionate use study that predated the current study; 3) one that does not require specific interventions (or one that does not dictate the regimen); or 4) one that does not include NP testing.

• A positive serum or urine pregnancy test, if female and of reproductive potential.