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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01033760
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute or primary HIV-1 infection
* Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.
* Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and \< 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
* Symptomatic Primary infection or CD4 \<500/mm3
* written informed consent
* ≥ 18 years old
Exclusion Criteria:
* Prior post exposure antiretroviral treatment within six months before enrolment
* Pregnancy or breast-feeding
* HIV-2 infection
* Current malignancy
* Prothrombin time \< 50%
* Creatinine clearance \< 60 ml/min
* ASAT, ALAT or bilirubin ≥10\*N
* Platelets \< 25000/mm3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01033760
Study Brief:
Protocol Section:
NCT01033760