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

This study has been completed.
Sponsor:
Collaborator:
Hoechst Marion Roussel
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000646
First received: November 2, 1999
Last updated: March 29, 2012
Last verified: March 2012

November 2, 1999
March 29, 2012
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00000646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS

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.

Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
Drug: Pentoxifylline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 1993
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000646
ACTG 160, 11135
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Hoechst Marion Roussel
Study Chair: Dezube B
Study Chair: Crumpacker C
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP