An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002091
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:

PRIMARY: To determine whether pentoxifylline changes the self-reported measures of quality of life status, using measures of scores from double-blinded drug withdrawal and drug restart periods.

SECONDARY: To measure the changes in monthly CD4 counts, fasting serum triglyceride levels, and weight; to assess the safety of pentoxifylline in HIV-infected persons.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Pentoxifylline Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Masking: Double
Primary Purpose: Treatment
Official Title: An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Stable antiretroviral therapy.
  • Maintenance medication for opportunistic infection.

Patients must have:

HIV positivity.


  • Patients on an antiretroviral must have received it for at least 2 months and have no currently perceived need to change or add to the regimen for the next 3 months.

Prior Medication:


  • Antiviral therapy (provided patient has been on such therapy for at least 2 months at study entry and dose is stable).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy (only patients who are 30 days from a diagnosis of an opportunistic infection and on appropriate maintenance medication are allowed).
  • Known significant intolerance or hypersensitivity to theophylline, theobromine (chocolate), or caffeine, for reasons other than dyspepsia.
  • Inability to swallow tablets (gastric feeding tubes are allowed).
  • Active bleeding disorder or major bleeding source, including peptic ulcer or gastritis.
  • Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.
  • Not willing to comply with visit schedule and study procedures.

Concurrent Medication:


  • Concurrent use of the anticoagulant warfarin (Coumadin) and heparin.

Prior Medication:


  • Treatment with biologic response modifiers (e.g., interferon, interleukin) within 14 days prior to study entry.

Prior Treatment:


  • Major surgery within 30 days of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002091

United States, Massachusetts
CRI of New England
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Community Research Initiative of New England

Cohen CJ, Dezube BJ, Day JM, Andradas V, Gagnon S, Rieker PP. The impact of pentoxifylline on quality of life. Int Conf AIDS. 1994 Aug 7-12;10(1):213 (abstract no PB0283) Identifier: NCT00002091     History of Changes
Other Study ID Numbers: 118A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 1993

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers