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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00458302
Eligibility Criteria:
Inclusion Criteria:
* Patients with documented HIV-1 infection
* Patients currently receiving HAART for at least 24 weeks
* Plasma viral load \< 50 copies/mL for at least 24 weeks prior to screening (two results must be documented)
* Patients taking the same antiretroviral combination for at least 8 weeks before screening
* Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity
* CD4 \> 100/mm3 at the start of HAART and \> 200/mm3 at screening.
Exclusion Criteria:
* No history of virological failure defined as two consecutive plasma HIV-1 RNA \> 500 copies/mL while on previous or current antiretroviral therapy
* No history of any primary PI mutations as defined by the IAS-USA guidelines 2006
* No patients co-infected with hepatitis B
* No pregnant or breastfeeding women
* No active clinically significant disease or life threatening disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00458302
Study Brief:
Protocol Section:
NCT00458302