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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT00001059
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* G-CSF.
* Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
* PCP prophylaxis (required if CD4 count \< 200 cells/mm3).
* Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
* Up to 14 days of metronidazole.
* Recombinant erythropoietin.
Patients must have:
* Documented HIV infection.
* Advanced stage Kaposi's sarcoma.
* No active acute opportunistic infection.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Significant pulmonary insufficiency (unless due to pulmonary KS).
* Significant cardiac insufficiency.
* Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
* Grade 2 or worse peripheral neuropathy.
* Altered mental status that prevents informed consent.
* Active Mycobacterium tuberculosis.
* Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).
Concurrent Medication:
Excluded:
* GM-CSF.
* Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).
* Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).
Concurrent Treatment:
Excluded:
* Radiation therapy to study marker lesions.
Patients with the following prior condition are excluded:
* Neuropsychiatric history.
Prior Medication:
Excluded:
* Any anti-KS therapy within 21 days prior to study entry.
* Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.
* Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.
PER AMENDMENT 11/29/95:
* No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00001059
Study Brief:
Protocol Section:
NCT00001059