Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008489
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-08-30
Brief Title:
Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
Sponsor:
PharmaResearch
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Trial Comparing the Tolerability of Videx EC Capsules to Videx Tablets in Adults With HIV Infection
Status:
UNKNOWN
Status Verified Date:
2002-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare gastrointestinal stomach and intestines side effects of 2 forms of Videx in HIV-infected patients
Videx can be an effective anti-HIV treatment but many patients will not take the medication due to its side effects Videx EC is a capsule form of the drug and may have fewer side effects Also patients would not have to take as many pills since patients taking Videx EC would have to take only 1 capsule per day instead of 2 tablets per day This study will see if patients taking Videx EC have fewer side effects
Videx can be an effective anti-HIV treatment but many patients will not take the medication due to its side effects Videx EC is a capsule form of the drug and may have fewer side effects Also patients would not have to take as many pills since patients taking Videx EC would have to take only 1 capsule per day instead of 2 tablets per day This study will see if patients taking Videx EC have fewer side effects
Detailed Description:
Despite its therapeutic advantages and proven efficacy in the treatment of HIV-infected patients didanosine may continue to be underutilized because many patients experience undesirable gastrointestinal GI side effects and palatability problems Once-daily dosing with Videx EC is expected to improve patient adherence with possible improved palatability and remove the GI side effects associated with the buffers included in the tablet Videx EC once-daily dosing would improve pill burden by decreasing from 2 tablets to 1 capsule per day Therefore Videx EC may represent a significant step toward achieving better patient satisfaction improved regimen adherence and optimal virologic outcomes with Videx-containing regimens
Patients are randomized to either continue their current Videx tablet-containing regimen for an additional 2 weeks or replace their Videx tablets with Videx EC Patients who remain on Videx tablets are switched to the EC formulation at Study Week 2 for the remaining 4 weeks of the study period For patients who continue and successfully complete the Week 6 study visit an optional extended dosing period is offered until Videx EC becomes commercially available or the study funder terminates the study Blood specimens for safety evaluations and viral load are collected at Weeks 0 1 2 4 and 6 For patients participating in the extended dosing period the visit schedule is every 8 weeks Symptom scores between the 2 treatment groups are compared with the primary comparison occurring at the Week 2 visit Analyses include changes in GSRS scores administered by clinician interview at each study visit Assessment of GI symptoms palatability features dosing convenience lifestyle effects and Videx preference is evaluated by the patient Adverse events are assessed objectively by the observations of both the investigator and the patient
Patients are randomized to either continue their current Videx tablet-containing regimen for an additional 2 weeks or replace their Videx tablets with Videx EC Patients who remain on Videx tablets are switched to the EC formulation at Study Week 2 for the remaining 4 weeks of the study period For patients who continue and successfully complete the Week 6 study visit an optional extended dosing period is offered until Videx EC becomes commercially available or the study funder terminates the study Blood specimens for safety evaluations and viral load are collected at Weeks 0 1 2 4 and 6 For patients participating in the extended dosing period the visit schedule is every 8 weeks Symptom scores between the 2 treatment groups are compared with the primary comparison occurring at the Week 2 visit Analyses include changes in GSRS scores administered by clinician interview at each study visit Assessment of GI symptoms palatability features dosing convenience lifestyle effects and Videx preference is evaluated by the patient Adverse events are assessed objectively by the observations of both the investigator and the patient
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMS-006 | None | None | None |