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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01383005
Eligibility Criteria:
Inclusion criteria:
1. Men or women aged 18 years or older, HIV-infected.
2. Patients who were under LPV/r Highly Active Anti-Retroviral Therapy (HAART) for 3 to 24 months before study visit:
Cohort 1: patients on LPV/r QD since they started the LPV/r regimen and who were naïve to protease inhibitor (PI) therapy.\* Cohort 2: patients who previously started on LPV/r BID (maximum of 24 months before study) and switched to LPV/r QD (at least 3 months before the study visit).\*
3. Patients who were able to complete questionnaires by themselves.
4. Patients who signed/dated informed consent to participate in the study.
* NOTE: Patients who were taking LPV/r QD should have had no more than 3 protease inhibitor mutations by the time the treatment with this LPV/r dosing was initiated.
Exclusion criteria:
1. Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit.
2. Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets.
3. Patients who were participating in any other clinical trial or postmarketing observational study (PMOS).
4. Patients who were unable to read and/or write.
5. Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01383005
Study Brief:
Protocol Section:
NCT01383005