HIV InfectionsNCT00002280
A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine
A study testing Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Didanosine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 1994
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Concomitant medications for the treatment of complications of AIDS.
- CAUTION:
- Concomitant use of ddI with the following drugs must be done with extreme caution:
- Other nucleosides (e.g., ganciclovir).
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- Drugs with toxicities similar to those observed with ddI (e.g., phenytoin).
- Drugs with significant pancreatic toxicities, including many drugs used for treatment of major opportunistic infections.
- Use of Sulfonamides or intravenous pentamidine for treatment of acute Pneumocystis carinii pneumonia (PCP) requires discontinuation of ddI for a week following treatment of PCP.
- Caution should also be exercised with patients having intractable diarrhea or patients following a low sodium diet.
- 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.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Acute pancreatitis or any history of pancreatitis.
- Seizures or a history of seizure disorder.
- Grade I or greater peripheral neuropathy.
- Preexisting cardiomyopathy.
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- Concurrent Medication:
- Excluded:
- Zidovudine (AZT).
- Chemotherapy with cytotoxic agents.
- AVOID:
- Those agents that may cause pancreatitis such as:
- Pentamidine.
- Sulfonamides.
- Antituberculosis drugs.
- Cimetidine.
- Ranitidine.
- Corticosteroids.
- NOTE the cautionary statement in Patient Inclusion Concurrent Medication.
- Patients with the following are excluded:
- Acute pancreatitis or any history of pancreatitis.
- Seizures or a history of seizure disorder.
- Grade I or greater peripheral neuropathy.
- Preexisting cardiomyopathy.
- Prior Medication:
- Excluded within 15 days of study entry:
- Any anti-retroviral except zidovudine (AZT).
- Required:
- Zidovudine (AZT).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol - Myers Squibb Co
Wallingford, Connecticut, 064927600
About this study
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)
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.
- Conditions
- HIV Infections
- Being tested
- Didanosine
- Keywords
- Didanosine, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002280
- Sponsor's protocol ID
- 039C
- Other IDs
- AI454-904
- Status last verified
- Aug 2011
- First submitted
- 2 Nov 1999
- Last updated
- 5 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00002280
- Acronym / sponsor ID
- 039C
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study completion
- Nov 1994 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Concomitant medications for the treatment of complications of AIDS.
- CAUTION:
- Concomitant use of ddI with the following drugs must be done with extreme caution:
- Other nucleosides (e.g., ganciclovir).
- Drugs with toxicities similar to those observed with ddI (e.g., phenytoin).
Key exclusion criteria (29 listed)
- Acute pancreatitis or any history of pancreatitis.
- Seizures or a history of seizure disorder.
- Grade I or greater peripheral neuropathy.
- Preexisting cardiomyopathy.
- Zidovudine (AZT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.