HIV Infections
Conditions
Keywords
Pentoxifylline, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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.
Interventions
DRUGPentoxifylline
Sponsors
Community Research Initiative of New England
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed