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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00480350
Eligibility Criteria:
Inclusion Criteria:
* Subjects with documented HIV-1 infection
* Male and female ages \> 18 years old
* Subjects who have given informed consent
* Subjects may either receive or not receive antiretroviral therapy at the time of enrollment
* Plasma HIV-1 RNA higher than 5000 copies/ml
* OR
* Patient CD4+ cell count less than 500 cells/mm3
* Patients who can comply with protocol requirements
Exclusion Criteria:
* Patients incapable of oral intake
* Patients who are allergic to rice
* Pregnant or breast-feeding women
* Active drug abuse which, in the opinion of the investigator, is expected to interfere with the subject's ability to adhere to the study procedures
* Active, clinically-significant disease or life-threatening disease that would compromise the subject's safety or outcome of the study
* Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol
* Patients who have started their anti-HIV treatment within less than 3 months from inclusion in the study. However, patients who have changed anti-HIV medication but have initiated therapy more than 3 months before inclusion will be eligible for the study.
* Patients known to suffer from diabetes mellitus
* Participation in any other clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00480350
Study Brief:
Protocol Section:
NCT00480350