Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Hoechst Marion Roussel

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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...

Detailed Description

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. Twen...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

March 1 1993

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT00000646

End Date

March 1 1993

Last Update

November 2 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States, 02215

2

Case CRS

Cleveland, Ohio, United States