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)
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Didanosine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .
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.
Clinical Details
Official title: 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)
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
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).
Exclusion Criteria
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.
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).
Locations and Contacts
Bristol - Myers Squibb Co, Princeton, New Jersey 085434500, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related 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)
Last updated: August 15, 2007
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