ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection

This study is ongoing, but not recruiting participants.
Study NCT00000652.   Last updated on July 29, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
Official Title  A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
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.

Detailed Description

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.

Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid. Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a higher dose of ddI than patients in part A. The first patients enrolled are given the lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Parallel Assignment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Zidovudine
Drug: Didanosine
MEDLINE PMIDs 8021765
Links Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site
Click here for more information about Didanosine This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  85
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

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.

Exclusion Criteria

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).

Prior Treatment:

Excluded:

  • Radiation therapy within 30 days.
  • Intravenous immunoglobulin preparations within 14 days of entry into study.
Gender Both
Ages 3 Months to 18 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000652
Organization ID ACTG 176
Secondary IDs †† NCI 91 C-09
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Study Chair:     PA Pizzo        
Study Chair:     RN Husson        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2006
First Received Date  November 2, 1999
Last Updated Date July 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers