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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT00379405
Eligibility Criteria:
Inclusion Criteria:
* Patients infected by HIV-1 (at least one documented positive Western-Blot).
* Age \> 18 years.
* Patients on antiretroviral treatment (standard HAART therapy) for at least six months.
* HIV-1 plasma viral load \<50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).
* Patients without evidence of previous virological failure to IP
* Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
* Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.
* Signature of the informed consent.
Exclusion Criteria:
* Suspicion of unsuitable antiretroviral treatment compliance.
* Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.
* Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
* Hepatic tests (AST, ALT, GGT) \> or equal to 5 times the upper limit of normality during the three months prior to the screening visit
* Presence of renal impairment (creatinine \> or equal to 1.5 times the upper limit of normality).
* Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.
* Participation in another clinical trial wich entail the antiretroviral treatment modification.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00379405
Study Brief:
Protocol Section:
NCT00379405