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


Phase 1
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Dezube B

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 160

NCT ID:

NCT00000646

Start Date:

Completion Date:

March 1993

Related Keywords:

  • HIV Infections
  • Pentoxifylline
  • Virus Replication
  • Tumor Necrosis Factor
  • Drug Evaluation
  • Acquired Immunodeficiency Syndrome
  • Cachexia
  • Drug Synergism
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Necrosis

Name

Location

Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Case CRSCleveland, Ohio  44106