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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT02191657
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged ≥18 years and ≤ 60 years.
* Absolute neutrophil count (ANC) of \>1000/mm3 for African black population and ≥ 1600/mm3 for all other races.
* For Cohort 2: HIV-negative
* For Cohorts 1 and 3: HIV-1 positive; CD4 count of at least 300/mm3; HIV-1 RNA copies (viral load) \>10 000 copies/mL serum; and current physical health stable and not requiring antiretroviral treatment
* For Cohorts 1 and 3: Chest x-ray showing absence of active infectious diseases (such as tuberculosis, viral or atypical bacteria or parasitic infection).
Exclusion Criteria:
* Presence of any severe concomitant disease.
* History of or current, recurrent or recent (4 weeks) febrile disease.
* History of opportunistic infections, neoplasm or AIDS-defining conditions.
* Inability to discontinue any medication from screening onwards, or for at least 2 weeks before the first admission; in particular any antiviral or therapy with immunosuppressive activity.
* Significant liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 2.5 times the upper normal limit.
* Significant kidney impairment: serum creatinine ≥ two times the upper normal limit.
* Any concomitant disorder or resultant therapy likely to have interfered with subject compliance or with study procedures.
* Known hypersensitivity to any of the test materials or related compounds.
* Positive test for Hepatitis B and/or C antibodies.
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
* History of seizures or epilepsy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02191657
Study Brief:
Protocol Section:
NCT02191657