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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pentoxifylline|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pentoxifylline, Acquired Immunodeficiency Syndrome, AIDS-Related Complex