Expired Study
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Boston, Massachusetts 02215


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.


Study 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.


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.


NCT ID:

NCT00000646


Primary Contact:

Study Chair
Dezube B


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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