Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
NCT ID: NCT00000646
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
1993-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Pentoxifylline
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hoechst Marion Roussel
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Dezube B
Role: STUDY_CHAIR
Crumpacker C
Role: STUDY_CHAIR
Locations
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Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Case CRS
Cleveland, Ohio, United States
Countries
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References
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Dezube BJ, Lederman MM, Pardee AB, Chapman B, Korvick J, Crumpacker CS. Pentoxifylline (Trental, PTX) decreases tumor necrosis factor (TNF) & may decrease HIV replication in AIDS patients. ACTG #160 Team. Int Conf AIDS. 1993 Jun 6-11;9(1):492 (abstract no PO-B28-2142)
Dezube BJ, Pardee AB, Chapman B, Beckett LA, Korvick JA, Novick WJ, Chiurco J, Kasdan P, Ahlers CM, Ecto LT, et al. Pentoxifylline decreases tumor necrosis factor expression and serum triglycerides in people with AIDS. NIAID AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Jul;6(7):787-94.
Dezube BJ, Pardee AB, Chapman B, Beckett L, Korvick J, Ahlers CM, Ecto L, Chatis P, Crumpacker CS. Pentoxifylline (trental) decreases tumor necrosis factor (TNF) and HIV replication in patients with AIDS. ACTG #160 Team. AIDS Clinical Trial Group. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0019)
Dezube BJ, Lederman MM, Spritzler JG, Chapman B, Korvick JA, Flexner C, Dando S, Mattiacci MR, Ahlers CM, Zhang L, et al. High-dose pentoxifylline in patients with AIDS: inhibition of tumor necrosis factor production. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. J Infect Dis. 1995 Jun;171(6):1628-32. doi: 10.1093/infdis/171.6.1628.
Dezube BJ, Pardee AB, Beckett LA, Ahlers CM, Ecto L, Allen-Ryan J, Anisowicz A, Sager R, Crumpacker CS. Cytokine dysregulation in AIDS: in vivo overexpression of mRNA of tumor necrosis factor-alpha and its correlation with that of the inflammatory cytokine GRO. J Acquir Immune Defic Syndr (1988). 1992;5(11):1099-104.
Other Identifiers
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11135
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 160
Identifier Type: -
Identifier Source: org_study_id