- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000997
A Study of Dideoxycytidine in HIV-Infected Patients
Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
To determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddC ) is given orally and how long the drug stays in the body after absorption or intravenous (IV) administration.
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Study Overview
Detailed Description
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.
Patients are hospitalized and receive ddC twice, once by mouth and once by IV injection. Each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. Following each dose, toxicity is measured before the next higher dose is given. Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Prior Medication:
Allowed:
- Oral nonabsorbable antifungal agents.
Exclusion Criteria
- Active drug or alcohol abuse.
Co-existing Condition:
- Patients with fever > 102 degrees F at study entry will be excluded.
- Patients with fever > 102 degrees F at study entry will be excluded.
Prior Medication: Excluded:
- Chronic systemic medications.
- Any other experimental drug within 2 weeks of study entry.
- Drugs with known nephrotoxic or hepatotoxic effects within 2 weeks of study entry.
- Drugs known to cause neutropenia within 2 weeks of study entry.
- Rifampin or rifampin derivatives, phenytoin, or barbiturates within 2 weeks of study entry.
- Any other medication except oral nonabsorbable antifungal agents within 72 hours of study entry.
All medications, including aspirin, must be approved by investigator. All medications, including aspirin, must be approved by investigator.
Patients must demonstrate the following clinical and laboratory findings:
- AIDS, AIDS related complex (ARC), or persistent generalized lymphadenopathy as defined by the CDC classification.
- No ascites.
- Off all medications except oral antifungal, nonabsorbable agents for 72 hours prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Lietman P
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 011
- 10987 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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