Completed

Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS

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What is being tested

Pentoxifylline

Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 2, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitlePentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 2, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
54 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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
Suspended
Beth Israel Deaconess - East Campus A0102 CRSBoston, United StatesSee the location
Suspended
Case CRSCleveland, United States

Completed2 Study Centers