A Study Comparing Two Forms of Didanosine in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00002360 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 14, 2011
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The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI.
Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may replace the need for antacids.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Didanosine | Phase 1 |
Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being developed.
Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are performed periodically during the study and at discharge. Serial blood samples are collected at specific time points over the 12 hours following dosing, and are used for the pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject within sequence, period, and formulation. Safety is assessed by monitoring adverse effects, vital signs, ECG recordings, and clinical laboratory tests throughout the study.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pivotal Bioequivalence Study of Videx Chewable/Dispersible Buffered Tablets and an Encapsulated Enteric Coated Bead Formulation of Didanosine in HIV-Infected Subjects |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | March 1999 |
Actual Study Completion Date : | March 1999 |


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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- HIV infection.
- CD4 cell counts of at least 200 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Any evidence of organ dysfunction.
- Any clinically significant deviations from specified baseline requirements for physical examinations, laboratory tests, or 12-lead electrocardiogram.

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): NCT00002360
Study Director: | Catherine A. Knupp |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00002360 History of Changes |
Other Study ID Numbers: |
039H 31876 AI454-157 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
Didanosine Tablets Reverse Transcriptase Inhibitors Anti-HIV Agents Therapeutic Equivalency |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases 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 |