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A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals Clinical research trials and A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals. A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals clinical trial. Human subjects often get the best healthcare possible for their A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals  A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,ICN Pharmaceuticals
Synopsis: To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity. To investigate antiviral activity of the combined regimen. Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).
Details: Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT). Patients receive ddI alone for 4 weeks, followed by 8 weeks of combination ddI/ribavirin. Patients who complete the first 12 weeks without major toxicity may receive an additional 12 weeks of combination therapy on an optional basis. Patients are followed for 60 days after the last treatment visit.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Stable maintenance or prophylaxis therapy for opportunistic infection, if such therapy was administered for at least 30 days prior to study entry. - Isoniazid for chemoprophylaxis against Mycobacterium tuberculosis. - Fluconazole for mucosal candidiasis or cryptococcosis. - Acyclovir (up to 1.0 g/day). - Dapsone. - Ketoconazole. - Quinolones. - Tetracycline. - Vitamins and herbal therapies. - Antibiotics as clinically indicated. - Systemic corticosteroids for < 21 days for acute problems. - Regularly prescribed medications. Patients must have: - HIV positivity by ELISA confirmed by Western blot. - CD4 count < 500 cells/mm3 within 30 days prior to study entry. - No active opportunistic infections requiring treatment (patients on stable maintenance and prophylaxis therapy for opportunistic infections for at least 30 days are permitted). NOTE: - Enrollment of women is encouraged. Prior Medication: Allowed: - Prior stable maintenance or prophylaxis therapy for opportunistic infection, if administered for at least 30 days prior to study entry. Exclusion Criteria Concurrent Medication: Excluded: - Concurrent rifampin or rifabutin. - Other anti-HIV drugs and investigational agents. - Biological response modifiers. - Ganciclovir or foscarnet. - Systemic cytotoxic chemotherapy. Concurrent Treatment: Excluded: - Concurrent radiation therapy other than limited localized therapy to the skin. Patients with the following prior conditions are excluded: - History of peripheral neuropathy. - History of pancreatitis or active liver disease. Prior Medication: Excluded: - Prior ddI. - Ribavirin within 60 days prior to study entry. - AZT or ddC within 2 weeks prior to study entry. Prior Treatment: Excluded: - Transfusion within 2 weeks prior to study entry. Active alcohol abuse.
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
JapourAJ, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 231;
Study Start Date:
Record last reviewed: February 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000772
Other Hiv Infections Studies:
1. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
2. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
3. Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients with Tuberculosis
4. Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
5. The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
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A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals
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