Search / Trial NCT00000646

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

Trial Information

Current as of December 14, 2024

Completed

Keywords

Pentoxifylline Virus Replication Tumor Necrosis Factor Drug Evaluation Acquired Immunodeficiency Syndrome Cachexia Drug Synergism

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.

Trial Officials

Dezube B

Study Chair

Crumpacker C

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Boston, Massachusetts, United States

Cleveland, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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