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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT00583167
Eligibility Criteria:
Inclusion Criteria:
* (All subjects in Groups A1, A2 and B):
* At least 18 years of age.
* No more than one month of ART in the past.
* No ART in the previous 3 months.
* Platelet count \>100,000 cells/mm3 on most recent determination within 60 days prior to first study lumbar puncture.
* Normal prothrombin time (PT) and partial thromboplastin time (PTT) on most recent determination within 60 days prior to first study lumbar puncture.
* Among individuals with past ART experience, the ability to construct an ART regimen predicted to completely suppress plasma HIV-1 RNA, based on results of viral susceptibility testing that is done as a routine part of clinical practice.
* Plasma HIV-1 RNA \>20,000 copies/mL.
* Additional Inclusion Criteria for Groups A1 and A2.
* Group A1:
* CD4+ T cell count \>200 cells/mm3.
* CSF HIV-1 RNA \>2,000 copies/mL on screening lumbar puncture.
* No history of significant allergy to beta lactam antibiotics, including penicillins and cephalosporins.
* No history of allergy to vancomycin.
* Group A2:
* CD4+ T cell count \<200 cells/mm3.
* CSF HIV-1 RNA \>2,000 copies/mL on screening lumbar puncture.
* No history of significant allergy to beta lactam antibiotics, including penicillins and cephalosporins.
* No history of allergy to vancomycin.
Exclusion Criteria:
* Evidence of CNS opportunistic infections or space occupying lesion.
* History of significant CNS disorder unrelated to HIV infection such as trauma, congenital malformations or genetic disorders.
* History of seizures.
* As determined by the investigator, a significant active or previous history of cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, or endocrine disease(s) that would interfere with study participation.
* Evidence or suspicion of vascular or Alzheimer's type dementias.
* Evidence or suspicion of Parkinson's disease.
* History of allergy to lidocaine.
* Implanted metal objects that make MRI contraindicated. This may require consultation with colleagues in the Vanderbilt Dept. of Radiology.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Women of childbearing potential (WOCBP) who are unwilling or unable to use an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00583167
Study Brief:
Protocol Section:
NCT00583167