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

This study has been completed.

Sponsored by: Community Research Initiative of New England
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002091
  Purpose

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 Intervention
HIV Infections
Drug: Pentoxifylline

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Pentoxifylline    Pentoxyl   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
Official Title:   An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   60

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

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

Patients must have:

HIV positivity.

NOTE:

  • 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:

Allowed:

  • 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:

Excluded:

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

Prior Medication:

Excluded:

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

Prior Treatment:

Excluded:

  • Major surgery within 30 days of study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002091

Locations
United States, Massachusetts
CRI of New England    
      Brookline, Massachusetts, United States, 02445

Sponsors and Collaborators
Community Research Initiative of New England
  More Information


Publications:
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)
 

Study ID Numbers:   118A, 91-02
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002091
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Pentoxifylline
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
Vasodilator Agents
Radiation-Protective Agents
RNA Virus Infections
Antioxidants
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Enzyme Inhibitors
Cardiovascular Agents
Infection
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Lentivirus Infections
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008




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