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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03407105
Eligibility Criteria:
Inclusion Criteria:
* Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL)
* CD4 count greater than or equal to 100 cells/mm3
* Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure
* Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy
* No significant organ compromise
Exclusion Criteria:
* Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening
* Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine
* History of autoimmune disease at risk for recurrence
* Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma
* Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc
* Currently undergoing treatment or prophylaxis for tuberculosis infection
* Chronic active infectious disease (other than HIV)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03407105
Study Brief:
Protocol Section:
NCT03407105