Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

NCT00000706 | Completed

• 2 other identifiers: ACTG 02711003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Quinine; Probenecid; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Quinine sulfate DRUG

Probenecid DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Kornhauser DM, Petty BG, Hendrix CW, Woods AS, Nerhood LJ, Bartlett JG, Lietman PS. Probenecid and zidovudine metabolism. Lancet. 1989 Aug 26;2(8661):473-5. doi: 10.1016/s0140-6736(89)92087-4.

  PMID: 2570186 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Quinine; Probenecid; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kornhauser D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: December 1, 1988
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)