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

• Status: Completed
• Trial end date: 1993-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Hoechst Marion Roussel
• Treatments: Pentoxifylline

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.