HIV InfectionsNCT00002028
A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
A study testing Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location. Read more about this study
- Who is it for?
- Ages 12 years and older
- 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 not given
- Phase
- Interventional
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Concomitant medications for the treatment of AIDS or ARC (including aerosolized pentamidine).
- Phenytoin, but with caution.
- Note:
- Extreme caution should be exercised in the use of ddI in any patient receiving concomitant therapies, particularly those receiving other nucleosides (e.g. ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections.
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- Patients must:
- Have a diagnosis of AIDS or be symptomatic, HIV positive, and have a CD4 cell count < 200 cells/mm3.
- Be intolerant to zidovudine (AZT) therapy. Not be suitable for study entry into the phase II didanosine (ddI) study by reason of inclusion or exclusion criteria or by reason of geographic location.
- Be able to provide signed informed consent (parent/guardian as appropriate). Be available for monthly follow-up while taking ddI. Meet baseline lab criteria within 14 days prior to initial drug dosing.
- Note:
- Extreme caution should be exercised in the use of ddI in any patient receiving concomitant therapies, particularly those receiving other nucleosides (e.g., ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections.
- Caution should also be exercised in a patient having intractable diarrhea or patients following a low-sodium diet. Physicians caring for patients must perform clinical and laboratory evaluations every 7 - 10 days for the first 2 months of ddI therapy. All high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with a history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided.
- Prior Medication:
- Allowed:
- Anti-emetic medication.
- Required:
- Zidovudine (AZT).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Malignancy likely to require chemotherapy in the first 3 months of ddI treatment.
- Acute pancreatitis.
- A poorly controlled seizure disorder.
- Grade B or greater peripheral neuropathy.
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- Concurrent Medication:
- Excluded:
- Zidovudine (AZT).
- Chemotherapy in the first 3 months of ddI treatment.
- Patients with the following are excluded:
- Malignancy likely to require systemic chemotherapy in the first 3 months of ddI treatment.
- Acute pancreatitis.
- A poorly controlled seizure disorder.
- Grade B or greater peripheral neuropathy.
- Prior Medication:
- Excluded within 15 days of study entry:
- Any antiretroviral drug except zidovudine (AZT).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol - Myers Squibb Co
Princeton, New Jersey, 085434500
About this study
The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location.
- Conditions
- HIV Infections
- Being tested
- Didanosine
- Keywords
- Didanosine, Drugs, Investigational, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002028
- Sponsor's protocol ID
- 040A
- Other IDs
- 454-999-001
- Status last verified
- Aug 2007
- First submitted
- 2 Nov 1999
- Last updated
- 16 Aug 2007
- Results posted
- No
Publications
Connolly KJ, Allan JD, Fitch H, Jackson-Pope L, McLaren C, Groopman J. A phase I study of 2'-3'-dideoxyinosine (ddI) administered orally twice daily to patients with AIDS or ARC and hematologic intolerance to azidothymidine (AZT). Int Conf AIDS. 1990 Jun 20-23;6(3):204 (abstract no SB473)