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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01168167
Eligibility Criteria:
Inclusion Criteria:
* Initiation of antiretroviral therapy, consisting of 2 nucleoside/ nucleotide reverse transcriptase inhibitors at physician's disposition plus a third substance, i.e. either raltegravir (n=10 patients) or a standard third substance (efavirenz or boosted protease inhibitor)
* Men or women with a documented HIV-1 infection, treated at the study center
* age at least 18 years old
* physical examination and vital signs, according to the treating physician do not give any hint for a active AIDS-defining illness or other serious disease
* patients are naive to cART or in therapy interruption for at least 3 months
* last available HIV-1 RNA was \>5,000 copies/mL within 3 months prior to cART initiation
* last available CD4-cell count showed at least 200 cells/µL within 3 months prior to cART initiation
* according to German-Austrian antiretroviral treatment recommendations, there is a given therapy indication
Exclusion Criteria:
* cART with other than the above mentioned drugs
* administration of concomitant drugs with relevant impact on antiretroviral's pharmacokinetics
* documented problems with patient visit- or medication-adherence
* any condition or disease requiring a medication that may interact relevantly with cART
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01168167
Study Brief:
Protocol Section:
NCT01168167