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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01543035
Eligibility Criteria:
Inclusion Criteria:
* On statin treatment for at least 3 months (fluvastatin, simvastatin, pravastatin, rosuvastatin, or atorvastatin) for primary prevention of cardiovascular disease
* HIV Ribonucleic Acid (RNA) below 50 copies/mL, minimum duration 3 months
* On a stable (\> 3 months) ARV treatment including at least one of the following drugs: LPV/r, ATZ/r, DRV/r, or EFV
* No previous virological escape or virological escape documented with a genotype at the time of failure only showing a K103M mutation.
Exclusion Criteria:
* Probability of cardiovascular complications of \> 20% according to the Swiss GSLA ("Groupe de travail Lipide et Athérosclérose"/Swiss Atherosclerosis Association) guidelines
* Previous cardiovascular disease (including stroke)
* Known diabetes
* Known intolerance of ETR
* Presence of a documented drug mutation (excluding the K103M)
* Regimen including non-boosted ATZ
* Known hyperlipidemia before ARV initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01543035
Study Brief:
Protocol Section:
NCT01543035