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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00421551
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV-1 infection.
* Documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry.
* CD4 count of 200 cells per mm3 or greater.
* Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry.
* Willing to use acceptable methods of contraception
Exclusion Criteria:
* Previous virological failure under prior PI-based regimen.
* Prior therapy in the darunavir.
* HIV-2 infected patients.
* Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Hepatitis B or C infection within 90 days prior to study entry.
* Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
* Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry.
* Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening
* Drug or alcohol use or any dependence that would interfere with compliance.
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00421551
Study Brief:
Protocol Section:
NCT00421551