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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT01453192
Eligibility Criteria:
Inclusion Criteria:
* Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
* HIV-1-infected patients treated by a three-drug ARV regimen
* Immuno-virologic criteria at renal transplantation: undetectable viral load (\<50 copies/mL) and CD4 \>200/mm3 for at least three months on stable ARV
* Age \>18 years and \<70 years
* Effective contraception for women
* Written informed consent
* Patient with social security coverage
Exclusion Criteria:
* Permanent:
* Hepatic cirrhosis
* Serious psychiatric illness history
* EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
* History of PML
* HTLV-1 seropositivity
* Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
* Patient with AgHBs+
* History of cryptosporidiosis
* History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
* Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
* Temporary:
* Recent malignancy (between 2 and 5 years according to type)
* HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
* Active infection
* HCV infection (PCR-positive)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01453192
Study Brief:
Protocol Section:
NCT01453192