Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT00624195
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00624195
Study Brief:
Protocol Section:
NCT00624195