Boston,
Massachusetts
02215
Purpose:
To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS
patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should
decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition
of zidovudine (AZT) activity.
Study summary:
Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such
TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine
(AZT) activity.
Twenty-seven AIDS patients with elevated TNF and less than 300 CD4 cells are given
pentoxifylline 3 times a day for 8 weeks. If no significant changes are seen in virologic,
immunologic, or related measures, 27 additional patients are given a higher dose of
pentoxifylline 3 times a day for eight weeks.
Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
- Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof,
at current dosage for the 8 weeks of study treatment.
- Prophylaxis (e.g., aerosolized pentamidine, trimethoprim / sulfamethoxazole (TMP /
SMX), dapsone for Pneumocystis carinii pneumonia (PCP) if CD4 cell count is < 200
cells/mm3
Allowed:
- Concurrent maintenance therapy for opportunistic infections.
Prior Medication: Required:
- Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof,
for at least 2 months.
Patients must have the following:
- Diagnosis of AIDS.
- Documented HIV seropositivity.
- Ability to give informed consent and willingness to comply with visit schedule and
all procedures.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Lymphoma or visceral Kaposi's sarcoma.
- Active peptic ulcer or bleeding disorder.
- Hemophilia. Known intolerance to pentoxifylline, theophylline, or caffeine.
Concurrent Medication:
Excluded:
- Warfarin and heparin.
- Biological response modifiers (e.g., erythropoietin, interferon, G-CSF, GM-CSF).
Cytotoxic chemotherapy.
- Megestrol acetate. Corticosteroids.
Concurrent Treatment:
Excluded:
- Radiation therapy. Blood products or transfusions.
Patients with the following are excluded:
- Presence of an active opportunistic infection.
- Major surgery within 30 days of study treatment.
Prior Medication:
Excluded:
- Biological response modifiers (including interferon, interleukin), corticosteroids,
or megestrol acetate within 14 days of first (screening) TNF level.
- Erythropoietin dependency or within 30 days of study treatment.
Prior Treatment:
Excluded:
- Transfusion or blood product dependency or use within 30 days of study treatment.