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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00158457
Eligibility Criteria:
Inclusion Criteria:
* Documented infection with HIV-1 (ELISA- Western Blot)
* Outpatient of masculine or feminine gender
* In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
* No previous treatment with antiretroviral therapy
* CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
* Patient has provided informed written consent
* Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator
Exclusion Criteria:
* Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
* Patient participating in a different clinical study
* Presence of serious or developing pathology
* Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
* Thrombocytopenia with platelet level under 50 000 cells /ml
* Known severe renal pathology (creatinine clearance under 50 ml/min)
* Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
* Karnofsky under 70 percent
* Opportunistic infections
* Patients taking medications not recommended in the context of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00158457
Study Brief:
Protocol Section:
NCT00158457