- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000706
Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects.
Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
In part I, four patients who are now receiving AZT at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of AZT defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. Part II studies the pharmacokinetics of AZT in eight patients receiving AZT at 1 of 2 doses and then at the lower dose of AZT plus probenecid with or without quinine.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must:
- Have symptomatic HIV infection.
- Be taking zidovudine (AZT), 100 or 200 mg, 5 or 6 x/day.
Allowed:
- History of Pneumocystis carinii pneumonia (PCP).
- Advanced AIDS related complex (ARC).
- HIV antibody positive with an absolute CD4 lymphocyte count of < 200 cells/mm3 before study entry.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions are excluded:
- Glucose-6-phosphate dehydrogenase deficiency.
- Allergy to sulfa drugs, probenecid, or quinine.
Concurrent Medication:
Excluded:
- Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Kornhauser D
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Antimetabolites
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Antimalarials
- Gout Suppressants
- Muscle Relaxants, Central
- Renal Agents
- Uricosuric Agents
- Zidovudine
- Quinine
- Probenecid
Other Study ID Numbers
- ACTG 027
- 11003 (DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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