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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT00187551
Eligibility Criteria:
Inclusion Criteria:
* Currently receiving continuous enfuvirtide-based antiretroviral therapy.
* Documentation of recent plasma HIV RNA level greater than the lower limit of detection (measured within the preceding 4 weeks)
* Screening plasma HIV-1 RNA level \> 1000 copies/mL.
* Negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry.
* Subjects must be able to give written informed consent and agree to abide by the requirements of the study.
Exclusion Criteria:
* Unstable HIV disease status such that interrupting any antiretroviral therapy poses significant short-term risk for disease progression (as determined by study investigators and referring primary care provider).
* Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
* Active hepatitis C infection requiring treatment with an interferon-based regimen.
* Evidence of active, untreated opportunistic infections or unexplained temperature which is \> 38.5°C for seven consecutive days, within 30 days prior to the first screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00187551
Study Brief:
Protocol Section:
NCT00187551