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A Study of Dideoxycytidine in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000997
First Posted: August 31, 2001
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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.


Condition Intervention
HIV Infections Drug: Zalcitabine

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection

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:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000997


Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Lietman P
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000997     History of Changes
Other Study ID Numbers: ACTG 011
10987 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Zalcitabine
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Biological Availability

Additional relevant MeSH terms:
Infection
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
Zalcitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents