An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002091
- Run by
- Community Research Initiative of New England
- People needed
- 60
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- CRI of New England — Brookline, Massachusetts, United States
Full record on ClinicalTrials.gov
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