Clinical trial NCT00624195 (phase 2/phase 3, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: fda approved antiretroviral therapy (see list below)
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Eligibility 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.