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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01453933
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* HIV-1 infection
* Treatment with antiretroviral regimen containing lopinavir/ritonavir for at least the previous 3 months
* No other protease inhibitors besides lopinavir/ritonavir in antiretroviral regimen
* Subjects must have a minimum period of viral suppression (plasma HIV-RNA \< 50 copies/ml) of 6 months
* Subjects will not have a history of virological failure on antiretroviral therapy
* Results of previous resistance testing allowing replacement of lopinavir/ritonavir by raltegravir
* CD4+ cell count \> 200 cells/µL
* Signed informed consent
Exclusion Criteria:
* Pregnancy
* Breastfeeding
* Raltegravir hypersensitivity
* Treatment of underlying malignancy
* Renal insufficiency requiring dialysis
* Acute or decompensated chronic hepatitis (Child-Pugh score C)
* Modification of antiretroviral regimen in the previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01453933
Study Brief:
Protocol Section:
NCT01453933