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

June 23, 2005 updated by: Community Research Initiative of New England

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • CRI of New England

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community Research Initiative of New England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Cohen CJ, Dezube BJ, Day JM, Andradas V, Gagnon S, Rieker PP. The impact of pentoxifylline on quality of life. Int Conf AIDS. 1994 Aug 7-12;10(1):213 (abstract no PB0283)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1993

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118A
  • 91-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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