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
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.
- Stable antiretroviral therapy.
- Maintenance medication for opportunistic infection.
Patients must have:
- 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.
- Antiviral therapy (provided patient has been on such therapy for at least 2 months at
study entry and dose is stable).
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
- 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 use of the anticoagulant warfarin (Coumadin) and heparin.
- Treatment with biologic response modifiers (e.g., interferon, interleukin) within 14
days prior to study entry.
- Major surgery within 30 days of study entry.