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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT00524368
Eligibility Criteria:
Inclusion Criteria:
* Patients with documented human immunodeficiency virus - Type 1 (HIV-1) infection
* Patients with a viral load greater than 1,000 HIV-1 ribonucleic acid (RNA) copies/mL
* Stable highly active antiretroviral therapy (HAART) regimen for at least 12 weeks at screening
* In the investigator's opinion, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are not a valid treatment option, because of the patient's antiretroviral (ARV) treatment history, ARV resistance testing, medication-taking behavior, safety and tolerability concerns, or other patient-related factors
* Prescreening or/and screening plasma HIV-1 RNA greater than 1,000 copies/mL on HAART regimen at screening
Exclusion Criteria:
* Presence of any currently active conditions that fit the definition of the World Health Organization (WHO) Clinical Stage 4, with the following exceptions: stable cutaneous kaposi's sarcoma (ie, no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study time period, wasting syndrome
* Patients for whom an investigational ARV is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval): tenofovir, emtricitabine
* Previous or current use of enfuvirtide (ENF), tipranavir and/or DRV
* Life expectancy of less than 12 months
* Pregnant or breast-feeding females
* Any active clinically significant disease (eg, tuberculosis \[TB\], cardiac dysfunction, pancreatitis, acute viral infections) 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:
NCT00524368
Study Brief:
Protocol Section:
NCT00524368