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)
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ClinicalTrials.gov Identifier: NCT00002028 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: August 16, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Didanosine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |


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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002028
United States, New Jersey | |
Bristol - Myers Squibb Co | |
Princeton, New Jersey, United States, 085434500 |
Principal Investigator: | . . |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00002028 History of Changes |
Other Study ID Numbers: |
040A 454-999-001 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | August 16, 2007 |
Last Verified: | August 2007 |
Keywords provided by Bristol-Myers Squibb:
Didanosine Drugs, Investigational Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome AIDS-Related Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Zidovudine Didanosine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |