A Study of Dideoxycytidine in HIV-Infected Patients - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000997

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:	Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zalcitabine

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	12
Primary Completion Date:	December 1988 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Click here for more information about Zalcitabine This link exits the ClinicalTrials.gov site

Publications:

Gustavson LE, Fukuda EK, Rubio FA, Dunton AW. A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS or AIDS-related complex. J Acquir Immune Defic Syndr. 1990;3(1):28-31.

ClinicalTrials.gov Identifier:	NCT00000997 History of Changes
Other Study ID Numbers:	ACTG 011
Study First Received:	November 2, 1999
Last Updated:	March 11, 2011
Health Authority:	United States: Federal Government

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:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Zalcitabine

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012