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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00002102
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor).
Patients must have:
* Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP).
* HIV positivity or be otherwise immunosuppressed.
* Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode.
* Consent of parent or guardian if less than 18 years of age.
NOTE:
* In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol.
Exclusion Criteria
Patients with the following prior conditions are excluded:
History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Study:
NCT00002102
Study Brief:
Protocol Section:
NCT00002102