Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
Pentoxifylline
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Treatment 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Beth Israel Deaconess - East Campus A0102 CRS
Boston, United StatesOpen Beth Israel Deaconess - East Campus A0102 CRS in Google MapsCase CRS
Cleveland, United States