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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT00946595
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV-1 infection
* Stable antiretroviral treatment over 6 months
* HIV-1 RNA \< 50 cp/mL for at least 12 months
* Lymphocytes CD4+ \> 200/mm3
* Lymphocytes CD4+ nadir \> 100/mm3
* Absence of prior treatment failure (defined by two successive HIV-1 RNA ≥ 50 cp/mL under NNRTI or PI treatment)
* Absence of documentation of a mutation conferring NRTI or NNRTI resistance or a primary mutation in the protease gene
* Written informed consent
* Patient affiliated to a social security scheme
Exclusion Criteria:
* Woman of child bearing potential without efficient contraception
* Pregnant or breastfeeding woman
* HBV infection (HbS Ag+)
* HBC infection requiring specific treatment during the trial
* Liver cirrhosis Child-Pugh C
* HIV-1/HIV-2 Co-infection or isolated HIV-2 infection
* Ongoing interleukin or interferon treatment
* Co-administration of contraindicated treatments
* Hypersensibility to efavirenz or lopinavir/r
* Absolute neutrophil count \< 750/mm3, hemoglobin \< 8g/dL, platelets \< 60.000/mm3, creatinine clearance \< 50 mL/min, ASAT, ALAT, lipase, alkaline phosphatase or total bilirubin \> 3 ULN, CD4 nadir \< 100/mm3.
* Participation in another clinical trial interfering with the study drug assignment in DREAM
* Subject under legal guardianship or incapacitation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00946595
Study Brief:
Protocol Section:
NCT00946595