Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Pentoxifylline |
Phase 1 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS |
Estimated Enrollment: | 54 |
Study Completion Date: | March 1993 |
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.
![](https://webarchive.library.unt.edu/web/20130228113804im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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United States, Massachusetts | |
Beth Israel Deaconess - East Campus A0102 CRS | |
Boston, Massachusetts, United States, 02215 | |
United States, Ohio | |
Case CRS | |
Cleveland, Ohio, United States |
Study Chair: | Dezube B | |
Study Chair: | Crumpacker C |
![](https://webarchive.library.unt.edu/web/20130228113804im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000646 History of Changes |
Other Study ID Numbers: | ACTG 160, 11135 |
Study First Received: | November 2, 1999 |
Last Updated: | March 29, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pentoxifylline Virus Replication Tumor Necrosis Factor Drug Evaluation |
Acquired Immunodeficiency Syndrome Cachexia Drug Synergism |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Necrosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes Pentoxifylline |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants |
ClinicalTrials.gov processed this record on February 26, 2013