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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

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ClinicalTrials.gov Identifier: NCT00000706
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Quinine sulfate Drug: Probenecid Drug: Zidovudine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Actual Study Completion Date : December 1988

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000706


Locations
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United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Kornhauser D
More Information
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Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000706    
Other Study ID Numbers: ACTG 027
11003 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Quinine
Probenecid
Drug Therapy, Combination
 Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zidovudine
Quinine
Probenecid
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents