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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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Community Research Initiative of New England ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60

Location and Contact Information:

CRI of New England
Brookline,  Massachusetts,  02445
United States
 


Additional Information:
Study ID Numbers:  118A;  91-02
Study Start Date: 
Record last reviewed: October 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002091

Other Hiv Infections Studies:
1. A Study of Nystatin in HIV-Infected Patients

2. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients

3. Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy

4. A Comparison of Two Anti-HIV Treatment Plans

5. Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

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