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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT00243568
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects with documented R5/X4 mixed-tropic HIV infection
* Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
* HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
* Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
* Acceptable hematologic, renal, and hepatic laboratory parameters.
Exclusion Criteria:
* No history of recurrent seizure or CNS condition predisposing to seizure
* No active AIDS-defining opportunistic infection
* Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
* Use of any drugs that predispose to seizures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00243568
Study Brief:
Protocol Section:
NCT00243568