A Study of Dideoxycytidine in HIV-Infected Patients

NCT00000997 | Completed

• 2 other identifiers: ACTG 01110987
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Zalcitabine; Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Biological Availability

Interventions

Zalcitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior Medication:
• Allowed:
• Oral nonabsorbable antifungal agents.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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 (1988). 1990;3(1):28-31.

  PMID: 2152803 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zalcitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Lietman P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: December 1, 1988
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)