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A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine Clinical research trials and A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine. A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine  A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.
Details: Patients currently on either AZT or ddI receive ganciclovir therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Concomitant AZT or ddI. Allowed: - Probenecid. - Aerosolized pentamidine. Patients must have: - Asymptomatic HIV infection. - CMV seropositivity or CMV culture positivity at present or at any time in the past. - No history of CMV disease (e.g., retinitis, colitis) or any other AIDS-defining illness. - Treatment with AZT or ddI for at least 1 month prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Uncontrolled diarrhea (three or more loose stools/day). - Clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain. - AZT patients only: - Deficiency in glucose-6-phosphate dehydrogenase. - ddI patients only: - Grade 2 or worse peripheral neuropathy. Concurrent Medication: Excluded: - Combination antiretroviral therapy. - G-CSF or GM-CSF. - Acyclovir. - Amphotericin B. - Amikacin. - Captopril. - Carbamazepine. - Cimetidine. - Cyclosporine. - Glutethimide. - Gentamicin. - Griseofulvin. - Ibuprofen. - Imipenem-Cilastatin. - Lithium. - Methicillin. - Methotrexate. - Naproxen. - Pentamidine (Pentam 300) (Aerosolized drug permitted). - Phenacetin. - Phenobarbital. - Phenytoin. - Piroxicam. - Ribavirin. - Rifampin. - Tobramycin. - Vidarabine. - Zalcitabine. - Other investigational drugs. Patients with the following prior conditions are excluded: - History of hypersensitivity to acyclovir or ganciclovir. - AZT patients only: - History of gout, uric acid, kidney stones, peptic ulcer or porphyria. - ddI patients only: - History of pancreatitis or alcoholism, or seizures within 6 months prior to study entry or prior need for anticonvulsant therapy. Prior Medication: Excluded: - Combination antiretroviral therapy within 1 month prior to study entry. Required: - AZT at 500 mg/day for at least 1 month prior to study entry (with 100 mg administered five times per day for at least 1 week prior to study entry). OR - ddI at recommended dose for at least 1 month prior to study entry (with 250 mg administered every 12 hours for at least 1 week prior to study entry). History of alcoholism (in ddI patients).
Total Enrollment: 24
Location and Contact Information:
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Ctr for Special Immunology
Irvine, California, 92718
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Additional Information:
Study ID Numbers: 059E; ICM 1776
Study Start Date:
Record last reviewed: November 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002096
Other Hiv Infections Studies:
1. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
2. A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
3. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
4. Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns with Symptomatic Congenital CMV Infection without Central Nervous System Disease
5. Prospective Study of HIV Infection in Hemophiliacs
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Other HIV Infections Clinical Trials
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A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
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