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

NCT00002091 | Completed

• 2 other identifiers: 118A91-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Pentoxifylline; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Pentoxifylline DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Community Research Initiative of New England: lead

Study Sites (1)

CRI of New England

Brookline, Massachusetts, 02445, United States

Location

Related Publications (1)

• 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1993-10

Locations

US (1)