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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00884858
Eligibility Criteria:
Inclusion Criteria:
* age \> or = 18
* HIV-Abs positivity detected by ELISA and confirmed by Western-Blot
* CD4 lymphocytes \< 200/uL and/or CD4 recovery \< 25% after at least 12 months of stable HAART
* HIV-RNA \< 50 cp/mL during the last 12 months
* negative pregnancy test at least 14 days prior to treatment
* understanding and signing the informed consent
Exclusion Criteria:
* allergy/intolerance to the study drug
* less than 1 year from any treatment with immunomodulatory agents
* current OIs or neoplasms
* current CVD or EKG abnormalities
* current respiratory tract diseases or COPD
* treatment with steroids within 4 weeks from treatment beginning
* suspect of autoimmune disorder or chronic inflammatory disease
* active IVDUs or alcohol addicts
* AST and ALT \> 2.5 ULD
* serum creatinine \> 1.5 ULD
* ANC \< 1000/uL
* hemoglobin \< 10 g/dL
* platelets \< 75.000/uL
* reticulocytes \> 2%
* Karnofsky score \< 50
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00884858
Study Brief:
Protocol Section:
NCT00884858