Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
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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 |
| Estimated Enrollment: | 12 |
| Study Completion Date: | December 1988 |
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 |
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 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 May 23, 2013