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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00849160
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected patients
* Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
* At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
* Naiive from darunavir
* Free from any opportunistic infection
* Creatinin \< 3N
* ASAT \& ALAT \< 5N
* Haemoglobin \> 7 g/dl
* Platelets \> 50 000/mm3
* Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
* Signed informed consent
Exclusion Criteria:
* HIV-2 infected patients
* Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
* Patients with a documented problem of treatment compliance within the last 12 months
* Ongoing active treatment against any opportunistic infection or tuberculosis
* Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
* Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
* Patient already treated with darunavir
* Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00849160
Study Brief:
Protocol Section:
NCT00849160