A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To determine the safety, pharmacokinetics (blood levels), and effectiveness of didanosine (ddI) when administered both intravenously and orally. After the maximum tolerated dose (MTD) is determined, an appropriate dosage regimen will then be established for Phase II and Phase III trials.

Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date, but it produces toxicity in approximately 50 percent of patients. Early data show that ddI possesses high antiviral activity and less toxicity than AZT. The most effective route and dose of ddI has yet to be determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date, but it produces toxicity in approximately 50 percent of patients. Early data show that ddI possesses high antiviral activity and less toxicity than AZT. The most effective route and dose of ddI has yet to be determined.

Patients are given intravenous drug for 14 days with a 1 day washout period, then 76 weeks of oral medication. To expedite this safety study and still be able to maintain close monitoring of the patient's health, an overlapping dosing regimen is used. After 6 patients have been enrolled and at least 4 have completed 4 weeks of dosing without significant toxic effects, a second group of patients is started at the next dose level.

AMENDED: An alternative oral dosing formulation of ddI will be provided as a buffer powder blend packaged in sealed foil sachets in several strengths.

Study Type

Interventional

Enrollment

42

Phase

  • Phase 1

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
    • New York
      • Buffalo, New York, United States, 14215
        • SUNY - Buffalo, Erie County Medical Ctr.

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

Concurrent Medication:

Recommended:

  • Allopurinol for consistent occurrence of hyperuricemia observed with 2',3'-dideoxyinosine (ddI) administration.

Allowed:

  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Oral acyclovir for herpes simplex infections provided ddI dosing is suspended during this time.
  • Ketoconazole for patients not responding to any other therapy and after consultation with the sponsor.
  • Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the principal investigator.
  • Aspirin rather than acetaminophen for fever.

Patients with the following will be included:

  • An absence of life-threatening opportunistic infection on enrollment.
  • A life expectancy less than 6 months.
  • Available for follow-up for at least 6 months.
  • Able to provide informed consent. Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Intractable diarrhea.
  • No venous access.
  • A history of or propensity for seizure disorders.
  • A history of past or current heart disease or other significant abnormality on routine EKG.

Concurrent Medication:

Excluded:

  • Adenine deaminase inhibitors.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii pneumonia (PCP) infections.
  • Antibiotics.
  • Acetaminophen for therapy of fever.

Patients with the following are excluded:

  • Intractable diarrhea.
  • A life expectancy less than 6 months.
  • No venous access.
  • A history of or propensity for seizure disorders.
  • A history of past or current heart disease or other significant abnormality on routine EKG.

Prior Medication:

Excluded:

  • Any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes.
  • Excluded within 2 weeks of study entry:
  • Trimethoprim / sulfamethoxazole.
  • Excluded within 1 month of study entry:
  • Any antiretroviral drug.
  • Investigational agents.
  • 2',3'-didanosine.
  • AL721.
  • Interferons.
  • Immunomodulating drugs.
  • Excluded within 3 months of study entry:
  • Ribavirin.
  • Cytotoxic agents.

Risk Behavior:

Excluded:

Active alcohol or drug abuse sufficient in the investigator's opinion to prevent adequate compliance.

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

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)

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)

May 1, 1990

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 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 064
  • 11038 (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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