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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00622232
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
* Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
* Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
* Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.
Exclusion Criteria:
* CD4 counts decreased by ≥25% from baseline in main study.
* Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
* Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
* Are breast-feeding.
* Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
* Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol
* Active HIV-related or non HIV-related illness
* Subjects who do not have additional cell product available
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00622232
Study Brief:
Protocol Section:
NCT00622232