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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02456558
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 positive
* HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen
* HIV-1 RNA \> 10,000 copies/mL
* ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range
* Body mass index (BMI) of 18.5 to 30.0 kg/m\^2
* Absolute neutrophil count at baseline of ≥1.0 x 10\^9/L (black African population only) or ≥1.5 x 10\^9/L (all other races)
Exclusion Criteria:
* Evidence of AIDS-associated illness, excluding superficial candidiasis
* CD4+ T-cell count of \< 350/mm\^3
* Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test
* Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening
* Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies
* History or presence of malignancy
* A serious, unstable chronic illness during the past 3 months before screening
* A serious, unresolved acute illness at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02456558
Study Brief:
Protocol Section:
NCT02456558