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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT00361933
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years
* Negative pregnancy test (for female participants)
* Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually
* Evidence of infection with HHV-8
* A willingness to travel and reside temporarily in Seattle for completion of the study protocol.
* For HIV-infected participants, a stable antiretroviral regimen for the past 6 months
Exclusion Criteria:
* Concurrent Kaposi sarcoma or non-hodgkin's lymphoma
* A history or evidence of CMV disease
* Hypersensitivity to ganciclovir or valganciclovir
* Use of high-dose acyclovir (\>800 mg bid), valacyclovir (\>1000 mg qd) or famciclovir (\>1000 mg qd), ganciclovir, foscarnet, or cidofovir
* Neutropenia (ANC \<1500)
* Renal insufficiency with serum creatinine \> 1.5 mg/ml or CrCl \< 60
* AST or ALT \> 5 times upper limit of normal
* Concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc)
* Concurrent administration of probenecid or didanosine.
* Inability to read and understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00361933
Study Brief:
Protocol Section:
NCT00361933