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Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks Clinical research trials and Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks. Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks clinical trial. Human subjects often receive the most effective healthcare possible for their Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks  Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.
Details: Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month. Patients are hospitalized overnight on three separate occasions. On the first admission, AZT is administered every 4 hours. On the second day, 15 blood samples are taken to determine how fast the AZT enters and is removed from the bloodstream (pharmacokinetics). On the second day, after all the blood specimens have been collected, patient starts taking probenecid by mouth every 8 hours, and is discharged from the research unit. The AZT dose is then taken every 8 hours. One week later and again 3 weeks after that, patient is readmitted overnight and the blood sampling to measure AZT levels is repeated. AMENDED: 8 additional patients will be enrolled using the same doses of AZT but a lower dose of probenecid.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Interferon. - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Concurrent Treatment: Allowed: - Radiation for skin lesions. Patients with symptomatic HIV infection taking zidovudine (AZT) five or six times a day as therapy. Includes patients with AIDS who have history of cytologically confirmed Pneumocystis carinii pneumonia (PCP), patients with advanced AIDS related complex (ARC), and HIV antibody positive patients. Patients must be able to give written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Allergy to probenecid. - Any underlying medical condition sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy. - History of urinary tract urate stones or gout. - Becoming acutely ill, unstable, or febrile. Concurrent Medication: Excluded: - Methotrexate. - Antiretroviral drugs. - Ganciclovir. - Amphotericin. - Experimental drugs. - Isoniazid. - Pyrazinamide. - Flucytosine. - Intravenous pentamidine. - Dapsone. - Fansidar. - Antineoplastic drugs not specifically allowed. - Trimethoprim / sulfamethoxazole. - Valproic acid. - Opiates. - Rifampin. - Sulfonylureas. Concurrent Treatment: Excluded: - Radiation not specifically allowed. Patients with the following are excluded: - Allergy to probenecid. - Any underlying medical condition sufficient, in investigator's opinion, to prevent adequate compliance with study therapy. - History of urinary tract urate stones or gout. - Becoming acutely ill, unstable, or febrile.
Total Enrollment: 16
Location and Contact Information:
Overall Study Official:
BGPetty, Study Chair,
UCD Med Ctr
Sacramento, California, 95817
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 107;
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000670
Other Hiv Infections Studies:
1. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
2. The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
3. A Study of BMY-27857 in Patients with AIDS or AIDS Related Complex
4. A Comparison of Two Types of Injected Nutritional Supplements in Patients with AIDS and Pneumocystis carinii Pneumonia (PCP)
5. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in HIV Positive Patients with CD4 Counts = or < 200: Treatment IND Study
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Safety and Tolerance of Zidovudine with Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
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