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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pentoxifylline
Sponsored by
Community Research Initiative of New England
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pentoxifylline, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CRI of New England

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Community Research Initiative of New England
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1. Study Identification

Unique Protocol Identification Number
NCT00002091
Brief Title
An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
Official Title
An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent
Study Type
Interventional

2. Study Status

Record Verification Date
October 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Community Research Initiative of New England

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Pentoxifylline, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pentoxifylline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

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