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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002091
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1993
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Pentoxifylline

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 60
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002091

Locations
United States, Massachusetts
CRI of New England
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Community Research Initiative of New England
  More Information

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)

ClinicalTrials.gov Identifier: NCT00002091     History of Changes
Other Study ID Numbers: 118A, 91-02
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Pentoxifylline
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
HIV Seropositivity
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014