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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002091
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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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
An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

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.

Not Provided
Interventional
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Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Pentoxifylline
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002091
118A
91-02
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Community Research Initiative of New England
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
October 1993

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