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| Descriptive Information Fields | |
| Brief Title † | A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine |
| Official Title † | An Open Label Study Regimen of Videx (2',3'-Dideoxyinosine, ddI) in Children With Acquired Immunodeficiency Syndrome (AIDS) Who Have Demonstrated Significant Deterioration or Intolerance to Zidovudine (Retrovir) |
| Brief Summary | The purpose of this study is to make didanosine (ddI) available to children with AIDS who are clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase II ddI programs due to protocol exclusion or geographic location. |
| Detailed Description | |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Didanosine |
| MEDLINE PMIDs | |
| Links | BMS Clinical Trials Disclosure ![]() For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  ![]() |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have the following: - Diagnosis of AIDS. Demonstrated either significant deterioration despite parenteral dosing with zidovudine (AZT) or significant intolerance to AZT. Signed informed consent by parent or legal guardian. Evaluations every 7-14 days while taking ddI for the first 4 months. Monthly follow-up is required thereafter. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded within 15 days of study entry:
Required:
|
| Gender | Both |
| Ages | 3 Months to 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002280 |
| Organization ID | 039C |
| Secondary IDs †† | AI454-904 |
| Study Sponsor † | Bristol-Myers Squibb |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Bristol-Myers Squibb |
| Verification Date | October 2007 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 27, 2008 |