HIV InfectionsPhase 1NCT00002360
A Study Comparing Two Forms of Didanosine in HIV-infected Patients
A Phase 1 study testing Didanosine in people with HIV Infections, run by Bristol-Myers Squibb.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Didanosine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 1999to Mar 1999
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have:
- HIV infection.
- CD4 cell counts of at least 200 cells/mm3.
Who cannot join
- 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.
About this study
Official title: Pivotal Bioequivalence Study of Videx Chewable/Dispersible Buffered Tablets and an Encapsulated Enteric Coated Bead Formulation of Didanosine in HIV-Infected Subjects
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Didanosine
- Keywords
- Didanosine, Tablets, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Therapeutic Equivalency
- Medical subject headings
- HIV Infections
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 startMar 1999
- Primary completionMar 1999
- Study completionMar 1999
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine A. Knupp, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002360
- Sponsor's protocol ID
- 039H
- Other IDs
- 31876, AI454-157
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Bioequivalence Study of Videx Chewable/Dispersible Buffered Tablets and an Encapsulated Enteric Coated Bead Formulation of Didanosine in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00002360
- Acronym / sponsor ID
- 039H
- Conditions
- HIV Infections
- Keywords
- Didanosine, Tablets, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 1999 (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 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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV infection.
- CD4 cell counts of at least 200 cells/mm3.
Key exclusion criteria (4 listed)
- Any evidence of organ dysfunction.
- Any clinically significant deviations from specified baseline requirements for physical examinations, laboratory tests, or 12-lead electrocardiogram.
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 14 Apr 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.
Catherine A. Knupp study director
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Didanosine in people with HIV Infections, run by Bristol-Myers Squibb.
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 3 inclusion and 4 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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 14 Apr 2011.