Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000706
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention
HIV Infections
Drug: Quinine sulfate
Drug: Probenecid
Drug: Zidovudine

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 12
Study Completion Date: December 1988
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000706

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Investigators
Study Chair: Kornhauser D
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000706     History of Changes
Other Study ID Numbers: ACTG 027, 11003
Study First Received: November 2, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Probenecid
Quinine
Zidovudine
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on April 17, 2014