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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01056393
Eligibility Criteria:
Inclusion Criteria:
* Capable of understanding and have voluntarily signed the ICF
* Have documented HIV-1 infection
* Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)
* Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure
* Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason
* Are able and willing to comply with all protocol requirements and procedures
* Are 18 years of age or older
* If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.
Exclusion Criteria:
* Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV
* Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
* Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
* Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01056393
Study Brief:
Protocol Section:
NCT01056393