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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Hoechst Marion Roussel |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000646 |
Purpose
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS |
| Estimated Enrollment: | 54 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Prior Medication: Required:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Cytotoxic chemotherapy.
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Study Chair: | Dezube B | |
| Study Chair: | Crumpacker C |
More Information
| Study ID Numbers: | ACTG 160 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000646 History of Changes |
| Health Authority: | United States: Federal Government |
|
Pentoxifylline Virus Replication Tumor Necrosis Factor Drug Evaluation |
Acquired Immunodeficiency Syndrome Cachexia Drug Synergism |
|
Vasodilator Agents Sexually Transmitted Diseases, Viral Radiation-Protective Agents Antioxidants Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Infection Pentoxifylline Necrosis Pathologic Processes Therapeutic Uses Free Radical Scavengers Retroviridae Infections |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Cardiovascular Agents Protective Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Phosphodiesterase Inhibitors HIV Infections Sexually Transmitted Diseases Lentivirus Infections Platelet Aggregation Inhibitors |