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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00225160
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged \> 18 years of age
* HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
* Women of childbearing potential must have a negative serum (beta-HCG; performed by a medical doctor - Austria only) pregnancy test within 28 days of starting study drug (and at monthly intervals for the duration for the trial (-Austria only)
* Ability to assess level of pain and complete a pain log
* Ability to understand and provide written informed consent to participation in this trial
* All clinical laboratory values must be considered not clinically significant - for the potential response to the planned new regimen - in the opinion of the investigator
* Naïve to antiretroviral therapy
Exclusion Criteria:
* Diminished ankle reflexes (compared to the knee) or absent ankle reflexes. OR
* Distal diminution of either vibration sense in the legs (defined as perception vibration \< 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) or pain or temperature sensation.
* Subjects who in the investigator's opinion are unlikely to complete the 48 weeks trial period.
* Subjects with current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations.
* Previous treatment with any drug known to induce peripheral neuropathy, specifically excessive alcohol, isoniazid \& vincristine.
* Subjects with insulin dependent diabetes or cancer and an existing peripheral neuropathy or hereditary neuropathy.
* Subjects with Vitamin B 12 deficiency (level \< 150pg/mL)
* Subjects using neurotoxic systemic therapeutic agents, systemic corticosteroids or immunomodulators within 30 days of randomisation.
* Use of a medication for neuropathic pain during 2 weeks prior to randomisation (including tricyclic antidepressants, mexilitene, phenytoin or carbamazepine).
* Subjects who have taken L-carnitine within 6 last months, or who have ever taken ALCAR.
* Subjects being pregnant or breast feeding.
* Subjects suffering from a serious medical condition, including one or more AIDS defining events (Appendix 8), which in the opinion of the investigator, would compromise the safety of the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00225160
Study Brief:
Protocol Section:
NCT00225160