Status:
COMPLETED
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Hoechst Marion Roussel
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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. Twen...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1993
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00000646
End Date
March 1 1993
Last Update
November 2 2021
Active Locations (2)
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1
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
2
Case CRS
Cleveland, Ohio, United States