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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00528593
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male or female ≥ 18 years old.
* Subject has documented HIV-1 infection.
* Subject has stable use or no use of specific dideoxynucleoside reverse transcriptase inhibitors (ie. ddI, d4T, ddc) for ≥4 months prior to Visit 1.
* Subject has painful HIV-associated sensory neuropathy (either DSP or ATN), as confirmed by a neurologist.
* Subject has an average severity of neuropathic pain over the 2 week period between visit 2 and Visit 3 of ≥0.74 units measured with the Gracely pain intensity scale.
* Subject (either male or female) agrees not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and use of contraception.
* Subjects hemoglobin is less than 13.0g/dl but greater than or equal to 10.0g/dl.
Exclusion Criteria:
* Subject has any condition other than HIV infection or antiretroviral therapy that in the opinion of the site neurologist confounds the diagnosis of neuropathy.
* Subject has received insulin or oral hypoglycemic products for treatment of diabetes mellitus £30 days from Visit 1.
* Subject has a documented history of untreated vitamin B12 deficiency (serum B12 level less than 200 pg/mL) or less than 3 months of B12 supplementation (injection or intranasal B12) prior to screening. Use of a multivitamin is permissible.
* Subject has hereditary neuropathy or compression-related neuropathies, i.e. spinal stenosis, that would preclude analysis of treatment response.
* Subject has received treatment with any drug other than the dideoxynucleoside analogues that the site neurologist considers to have significantly contributed to the subject's neuropathy ≤30 days from Visit 1.
* Subject has a history of any alcohol-related medical complications within 6 months of Visit 1 including, but not limited to, alcohol withdrawal seizures, hallucinosis, delirium tremens, or being in a detoxification program.
* Subject has received neurotoxic chemotherapeutic agents £90 days from Visit 1.
* Subject has received neuroregenerative agents £90 days from Visit 1.
* Subject has myelopathy that would interfere with the evaluation of the subject.
* Subject has uncontrolled hypertension (Systolic Bp\>160mmHg and/or Diastolic Bp \>100mmHg)
* Subject has known hypersensitivity to mammalian cell-derived products or albumin.
* Subject has a history of thrombotic events or epileptic seizures.
* Subject has an active AIDS-defining opportunistic infection (OI) or OI-defining condition £30 days from Visit 1.
* Subject has active major disease, both HIV-related and non-HIV-related including, but not limited to, cardiac disease, pulmonary, or hepatorenal, which in the opinion of the investigator might affect the study.
* Subject is pregnant or breast-feeding.
* Subject has any currently active malignancy, or a history of any previous malignancy with the exception of skin squamous cell carcinoma or basal cell carcinoma.
* Subject has received any investigational agent(s) that is not FDA-approved or has participated in any interventional research study £30 days from Visit 1.
* Subject is actively using recreational intravenous drugs, crack cocaine, or intranasal/smoked heroin or methamphetamine.
* Subject has chronic renal failure defined for the purposes of this study as a creatinine \>1.5 x upper limit of normal (ULN).
* Subject has hepatitis C and is on interferon/ribavirin therapy or interferon/ribavirin therapy is planned over the expected course of the study.
* Subject has received epoetin alfa (Procrit) within 2 months prior to study entry.
* Subject has HgbA1C \>6.5.
* Subject has serum B12 ≤200 pg/mL.
* Subject has hemoglobin \<11.0 g/dL.
* Subject has INR \>1.4 or platelets \<50,000.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00528593
Study Brief:
Protocol Section:
NCT00528593