Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect 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.

Gender

ALL

Eligibility 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.