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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00723918
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection
* HIV-associated neuropathy diagnosed by a neurologist
* Presence of at least a moderate pain score on the basis of completion of a baseline pain diary
* Stable antiretroviral regimen for at least 8 weeks prior to study entry.
* Hemoglobin ≥ 8.0 g/dL for males and ≥ 7.5 g/dL for females
Exclusion Criteria:
* Active AIDS-defining opportunistic infection within 45 days prior to study entry
* Renal insufficiency
* Chronic liver disease
* B12 deficiency
* Family history of hereditary neuropathy
* Discontinuation of dideoxynucleoside NRTI within 16 weeks prior to entry
* On neuroregenerative therapy
* Treatment with neurotoxic drugs within 120 days prior to entry
* Respiratory compromise
* Hypotension
* Active substance abuse or dependence
* History of alcohol-related complications within 6 months prior to screening
* Women of childbearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00723918
Study Brief:
Protocol Section:
NCT00723918