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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT00355251
Eligibility Criteria:
Inclusion Criteria:
1. Age \>= 18 years.
2. Patients with chronic infection by HIV-1 in stable highly active antiretroviral treatment (\>= 6 months).
3. Undetectable plasma viral load (\<50 copies/mL) in the last 3 determinations over the last 6 months.
4. CD4 \> 500 cells/mm\>=3 in the last two determinations.
5. Documented prior viral load at some time of \>15,000 copies/mL.
6. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
7. Signature of the informed consent
Exclusion Criteria:
1. CD4 nadir \<= 200 cells/mm3.
2. Background of infections or other AIDS-defining pathology.
3. Intercurrent infections in the last 6 months.
4. Creatine kinase (CK) \>= 500 U/L.
5. AST or ALT \>= 3 times higher than the upper limit of normality.
6. Treatment with others statins, fibrates, macrolides or fluconazole in the last 3 months.
7. Pregnancy or breastfeeding
8. Patients participating in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00355251
Study Brief:
Protocol Section:
NCT00355251