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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00002251
Eligibility Criteria:
Inclusion Criteria
Patients must have the following:
* Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
* Documented confirmation of present or past CMV infection.
* Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
Concurrent Medication:
Excluded:
* Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.
Patients with the following are excluded:
* Any concomitant conditions listed in Exclusion Co-Existing Conditions.
* Karnofsky score \< 70.
* Hypersensitivity to acyclovir.
* Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.
Prior Medication:
Excluded:
* Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
* Excluded within 4 days of study entry:
* Antimetabolites.
* Interferons.
* Other nucleoside analogs.
* Zidovudine (AZT).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
60 Years
Study:
NCT00002251
Study Brief:
Protocol Section:
NCT00002251