Status:
COMPLETED
Clinical Trial of CNS-targeted HAART (CIT2)
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
"HIV Neurocognitive Disorders: A Randomized Clinical Trial of CNS-targeted HAART" is a randomized, controlled clinical trial to assess the efficacy of a strategy for targeting highly active antiretrov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00624195
Start Date
March 1 2007
End Date
June 1 2012
Last Update
April 23 2014
Active Locations (5)
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1
HIV Neurobehavioral Research Center, University of California San Diego
San Diego, California, United States, 92103
2
University of California, San Francisco
San Francisco, California, United States, 94110
3
Johns Hopkins University- School of Medicine
Baltimore, Maryland, United States, 21287
4
Washington University
St Louis, Missouri, United States, 63110