NCT00000669

Brief Summary

To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given orally and intravenously, in infants and children with AIDS. The study also measures bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a preliminary assessment of the effectiveness of ddI on HIV replication. AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

August 26, 2008

Status Verified

October 1, 1996

First QC Date

November 2, 1999

Last Update Submit

August 25, 2008

Conditions

HIV Infections

Keywords

DidanosineDrug EvaluationAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

DidanosineDRUG

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis if this drug is extended to children.
  • Acute therapy not exceeding 7 days with oral or intravenous acyclovir for herpes simplex infections.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections during course of study at discretion of investigator after discussion with the sponsor.
  • Symptomatic therapy with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy as deemed necessary by the principal investigator.
  • Patients must have:
  • Diagnosis of AIDS as defined by CDC or meeting CDC P2 classification.
  • Patients must be free of opportunistic infection or other serious bacterial, fungal, or parasitic infection at time of entry into study.
  • Life expectancy \> 6 months.
  • Parent or guardian (and patient as applicable) able to give informed consent.
  • Available for follow-up for at least 6 months.
  • Allowed: Hemophilia.

You may not qualify if:

  • Co-existing Condition:
  • Children with the following are excluded:
  • Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
  • Intractable diarrhea.
  • No venous access.
  • History of seizures within previous 2 years or currently requiring anticonvulsants for control.
  • Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of \< 10 percent on echocardiogram.
  • Renal disease.
  • Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral drugs.
  • Zidovudine (AZT).
  • AL 721.
  • Interferon.
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

The Regional Medical Ctr, Memphis

Memphis, Tennessee, 38105, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Univ TX Health Science Ctr

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Butler KM, Husson RN, Balis FM, Brouwers P, Eddy J, el-Amin D, Gress J, Hawkins M, Jarosinski P, Moss H, et al. Dideoxyinosine in children with symptomatic human immunodeficiency virus infection. N Engl J Med. 1991 Jan 17;324(3):137-44. doi: 10.1056/NEJM199101173240301.

    PMID: 1670591BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

InosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Scott GB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

August 26, 2008

Record last verified: 1996-10

Locations

US(5)