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

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

Sponsors

Lead sponsor: Community Research Initiative of New England

Source NIH AIDS Clinical Trials Information Service
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.

Overall Status Completed
Phase N/A
Study Type Interventional
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: Pentoxifylline

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility CRI of New England
Location Countries

United States

Verification Date

October 1993

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov