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:
Community Research Initiative of New England
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Pentoxifylline
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
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:
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pentoxifylline Phosphodiesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants |
ClinicalTrials.gov processed this record on May 23, 2013