A Study of Dideoxycytidine in HIV-Infected Patients

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Lietman P

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

December 1, 1988

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

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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