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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000706 |
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: | Treatment, Open Label |
| Official Title: | Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine |
| Estimated Enrollment: | 12 |
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:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions are excluded:
Concurrent Medication:
Excluded:
- Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT).
Contacts and Locations More Information
| Study ID Numbers: | ACTG 027 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000706 History of Changes |
| Health Authority: | United States: Federal Government |
|
Quinine Probenecid Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Quinine Physiological Effects of Drugs Zidovudine Neuromuscular Agents Infection Renal Agents Gout Suppressants Reverse Transcriptase Inhibitors Antimalarials |
Antiparasitic Agents Anti-Retroviral Agents Sensory System Agents Muscle Relaxants, Central Therapeutic Uses Probenecid Analgesics Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents |
