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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000646

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

54

Expected to finish

1993-03-01

Last updated by the study team

2021-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Case CRS — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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