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A Study of Dideoxycytidine in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zalcitabine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000997
Brief Title
A Study of Dideoxycytidine in HIV-Infected Patients
Official Title
Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1988 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Biological Availability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lietman P
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2152803
Citation
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.
Results Reference
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A Study of Dideoxycytidine in HIV-Infected Patients

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