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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT00000695
Eligibility Criteria:
Inclusion Criteria
Concurrent Treatment:
Allowed:
* Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial.
Patients must demonstrate the following clinical and laboratory findings:
* Positive for HIV by federally licensed ELISA test.
* Acceptable bone marrow function.
* Acceptable renal function.
* Acceptable hepatic function.
Exclusion Criteria
Concurrent Medication:
Excluded:
* Other potentially antiretroviral compounds.
Patients will be excluded from the study for the following reasons:
* Concurrent, active opportunistic infections requiring therapy.
* Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma.
* Evidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV).
* History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix.
* Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1.
Prior Medication:
Excluded:
* More than one chemotherapy regimen for Kaposi's sarcoma.
* Any interferon preparation or zidovudine (AZT).
* Excluded within 30 days of study entry:
* Other immunomodifiers.
* Acyclovir.
* Other investigational drugs.
* Excluded within 60 days of study entry:
* Cytotoxic therapy.
Patients may not have any of the following diseases or symptoms:
* Development of an AIDS-defining opportunistic infection, other than oral thrush or localized zoster.
* Non-Kaposi's sarcoma, AIDS-defining malignancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00000695
Study Brief:
Protocol Section:
NCT00000695