Completed

Pentoxifylline Impact on Quality of Life in HIV-Positive Individuals

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What is being tested

Pentoxifylline

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorCommunity Research Initiative of New England
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-positive individuals who are experiencing symptoms of HIV infection and have a specific Karnofsky score, which is a way to measure a person's ability to perform daily activities. The study aims to evaluate the effects of a drug called pentoxifylline on these individuals. The main goal is to see if pentoxifylline can improve the self-reported quality of life in these patients during periods when the drug is stopped and restarted in a controlled, double-blinded manner. This research is important as it may provide a new treatment option to enhance the quality of life for individuals living with HIV. During the study, participants will take pentoxifylline and their progress will be tracked in various ways. The study will measure changes in monthly CD4 counts, which are a type of white blood cell that fights infection and is often affected in HIV patients. It will also monitor fasting serum triglyceride levels, which are a type of fat found in the blood, and weight. Additionally, the safety of pentoxifylline in HIV-infected persons will be assessed.

NCT00002091
Principal SponsorCommunity Research Initiative of New England
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

5 inclusion criteria required to participate
Allowed: Stable antiretroviral therapy.
Allowed: Maintenance medication for opportunistic infection.
Patients must have HIV positivity.
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.
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9 exclusion criteria prevent from participating
Patients with 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).
Active bleeding disorder or major bleeding source, including peptic ulcer or gastritis.
Known significant intolerance or hypersensitivity to theophylline, theobromine (chocolate), or caffeine, for reasons other than dyspepsia.
Treatment with biologic response modifiers (e.g., interferon, interleukin) within 14 days prior to study entry.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CRI of New England

Brookline, United StatesOpen CRI of New England in Google Maps
CompletedOne Study Center