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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00000660
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
AMENDED:
* 04-21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the reduced dose before starting AZT. Zidovudine will not be provided by the NIAID Clinical Product Research Repository.
AMENDED:
* Zidovudine (AZT) allowed after completing 12 weeks on study.
Allowed:
* Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP).
Concurrent Treatment:
Allowed:
* Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions provided the dose to any one lesion does not exceed 300 rads and the total surface area of all lesions treated does not exceed 10 cm2.
Risk Behavior:
Allowed:
* All risk groups.
Patients must:
* Have AIDS-related Kaposi's sarcoma.
* Be ineligible for protocols of higher priority at study center.
* Be willing to sign an informed consent or have guardian willing to sign.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Active opportunistic infection not specifically allowed.
* Concurrent neoplasm not specifically allowed.
* Significant neurologic, cardiac, or liver disease.
Concurrent Medication:
Excluded:
* Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an opportunistic infection.
Patients with the following are excluded:
* Active opportunistic infection not specifically allowed.
* Ongoing therapy, including maintenance therapy, for an opportunistic infection with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs.
* Concurrent neoplasm not specifically allowed.
* Significant neurologic, cardiac, or liver disease.
Prior Medication:
Excluded:
* Biologic response modifiers or corticosteroids within 14 days prior to study entry.
* Cytotoxic chemotherapy within 30 days prior to study entry.
* Ribavirin within 6 weeks prior to study entry.
* Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any other antiretroviral drugs within 1 week prior to study entry.
Prior Treatment:
Excluded within 30 days prior to study entry:
* Radiation therapy with \> 4000 rads.
* Total skin electron beam therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000660
Study Brief:
Protocol Section:
NCT00000660