A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT, ddI, ddC, or d4T provided patients have received at least 2 weeks of this therapy prior to study entry. (Combination ddI/ddC is not permitted.)
* MAI prophylaxis.

Required in patients with CD4 count \< 200 cells/mm3:

Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone as PCP prophylaxis.

Patients must have:

* HIV infection.
* Cutaneous Kaposi's sarcoma.
* Life expectancy of at least 3 months.
* Consent of parent or guardian if under 18 years of age.

NOTE:

* This protocol is considered suitable for prison populations.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Peripheral neuropathy (grade 2 or worse).
* Underlying severe or life-threatening infection with bacterial, viral, fungal, or protozoal pathogens.
* Known hypersensitivity to TNP-470, fumagillin, or known related compounds.

PER AMENDMENT 9/3/96:

* Cataracts.

Concurrent Medication:

Excluded:

* Combination therapy with ddI/ddC (although these drugs may be administered alone or in combination with AZT).
* Anticonvulsive medication.
* Steroids.
* Antineoplastic drugs.
* Interferons.
* Systemic or topical anti-Kaposi's sarcoma agents or regimens.
* Suramin.
* Aspirin.
* Warfarin.
* Heparin (including heparin flushes).
* Nonsteroidal anti-inflammatory drugs.
* Investigational status drugs.

Patients with the following prior conditions are excluded:

* History of substantial non-iatrogenic bleeding disorders.
* History of tumor or malignancies other than Kaposi's sarcoma, with the exception of completely resected basal cell skin carcinoma or in situ cervical carcinoma.
* History of seizures within the past 10 years.

PER AMENDMENT 9/3/96:

* History of cataracts.

Prior Medication:

Excluded within 4 weeks prior to study entry:

* Steroids.
* Antineoplastic drugs.
* Interferons.
* Systemic or topical anti-Kaposi's sarcoma agents or regimens.

Excluded within 6 months prior to study entry:

* Suramin.

Unwilling to refrain from unprotected sexual contact or other activities that may result in HIV re-infection.