NCT00000652

Brief Summary

To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

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

Study Completion

Last participant's last visit for all outcomes

November 1, 1995

Completed
4 years until next milestone

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

November 1, 2012

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

October 31, 2012

Conditions

HIV Infections

Keywords

DidanosineDrug EvaluationDrug Therapy, CombinationZidovudine

Interventions

ZidovudineDRUG
DidanosineDRUG

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Corticosteroids for treatment of lymphocytic interstitial pneumonitis.
  • Concurrent Treatment:
  • Allowed:
  • Intravenous hyperalimentation.
  • Patients must have the following:
  • P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is \< 500 cells/mm3.
  • Freedom from significant active opportunistic or other infection requiring specific therapy.
  • Part B patients:
  • Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.
  • Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
  • History of acute or chronic pancreatitis.
  • Patients with the following are excluded:
  • Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
  • History of acute or chronic pancreatitis.
  • Prior Medication:
  • Excluded:
  • Antiretroviral or other antiviral agent within 14 days of entry into study.
  • Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis).
  • Part A patients:
  • Zidovudine (AZT) or didanosine (ddI).
  • Part B patients:
  • Didanosine (ddI).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, California, 900276016, United States

Location

Related Publications (1)

  • Mueller BU, Pizzo PA, Farley M, Husson RN, Goldsmith J, Kovacs A, Woods L, Ono J, Church JA, Brouwers P, et al. Pharmacokinetic evaluation of the combination of zidovudine and didanosine in children with human immunodeficiency virus infection. J Pediatr. 1994 Jul;125(1):142-6. doi: 10.1016/s0022-3476(94)70141-5.

    PMID: 8021765BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

ZidovudineDidanosine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosides

Study Officials

  • PA Pizzo

    STUDY CHAIR

  • RN Husson

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

November 1, 1995

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(1)