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Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS Clinical research trials and Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS. Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS clinical trial. Participants frequently get the best healthcare available for their Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS  Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoechst Marion Roussel
Synopsis: To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.
Details: Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity. Twenty-seven AIDS patients with elevated TNF and less than 300 CD4 cells are given pentoxifylline 3 times a day for 8 weeks. If no significant changes are seen in virologic, immunologic, or related measures, 27 additional patients are given a higher dose of pentoxifylline 3 times a day for eight weeks.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, at current dosage for the 8 weeks of study treatment. - Prophylaxis (e.g., aerosolized pentamidine, trimethoprim / sulfamethoxazole (TMP / SMX), dapsone for Pneumocystis carinii pneumonia (PCP) if CD4 cell count is < 200 cells/mm3 Allowed: - Concurrent maintenance therapy for opportunistic infections. Prior Medication: Required: - Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), or a combination thereof, for at least 2 months. Patients must have the following: - Diagnosis of AIDS. - Documented HIV seropositivity. - Ability to give informed consent and willingness to comply with visit schedule and all procedures. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Lymphoma or visceral Kaposi's sarcoma. - Active peptic ulcer or bleeding disorder. - Hemophilia. Known intolerance to pentoxifylline, theophylline, or caffeine. Concurrent Medication: Excluded: - Warfarin and heparin. - Biological response modifiers (e.g., erythropoietin, interferon, G-CSF, GM-CSF). Cytotoxic chemotherapy. - Megestrol acetate. Corticosteroids. Concurrent Treatment: Excluded: - Radiation therapy. Blood products or transfusions. Patients with the following are excluded: - Presence of an active opportunistic infection. - Major surgery within 30 days of study treatment. Prior Medication: Excluded: - Biological response modifiers (including interferon, interleukin), corticosteroids, or megestrol acetate within 14 days of first (screening) TNF level. - Erythropoietin dependency or within 30 days of study treatment. Prior Treatment: Excluded: - Transfusion or blood product dependency or use within 30 days of study treatment.
Total Enrollment: 54
Location and Contact Information:
Overall Study Official:
DezubeB, Study Chair,
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 160;
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000646
Other Hiv Infections Studies:
1. HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
2. Psychosocial Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children
3. Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
4. Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
5. A Study of Peldesine (BCX-34) in HIV-Infected Patients
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Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS
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