An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
NCT ID: NCT00002091
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Pentoxifylline
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Community Research Initiative of New England
OTHER
Locations
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CRI of New England
Brookline, Massachusetts, United States
Countries
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References
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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)
Other Identifiers
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91-02
Identifier Type: -
Identifier Source: secondary_id
118A
Identifier Type: -
Identifier Source: org_study_id