Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268827
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-12-22
Brief Title:
A Comparison Study of Kaletra Soft-Gel Capsules and Kaletra Tablets in an African American Cohort
Sponsor:
AIDS Arms Inc
Organization:
AIDS Arms Inc
Study Overview
Official Title:
A Comparison of Adverse Events and Quality of Life Before and After Switching From Kaletra Soft-Gel Capsules SGC to Kaletra Tablets in an African American Cohort
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
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 Kaletra tablets with Kaletra soft-gel capsules to see if there is any change in the side effects you may have and to see how people in the study feel about using the tablets
Detailed Description:
The demand for once-a-day easily tolerated therapies is increasing While Abbott Laboratories 418 study has demonstrated the efficacy of Kaletra with both BID and QD dosing with capsules the pill count of QD dosing may decrease its attractiveness for this population In some patients issues such as diarrhea nausea food restrictions or the need to refrigerate their medication may also impact quality of life and possibly lead to non adherence and ultimately treatment failure Moreover it is believed that the diarrhea associated with Kaletra capsules may be the result of capsule excipients that are unrelated to the active drug
Kaletra has a long track record of being highly potent and not selective for protease inhibitor resistance as evidence by the Phase II Study 720 The results of this study demonstrate that ABT-378ritonavir therapy is highly potent durable and well tolerated when administered concomitantly with two nucleoside analog reverse transcriptase inhibitors to antiretroviral-naïve HIV-1 infected individuals A high proportion of subjects achieved normal viral suppression 50 copiesml - 78 by ITT No discontinuations due to study drug -related clinical or laboratory adverse events occurred during the first 48 weeks of study but the most common adverse effect was diarrhea 25 Given the high oleic content of the capsules dosing all six capsules at once may cause a bolus of this acid leading to increased diarrhea Because of the viral suppression advantages there is desire to see if there is a difference in quality of life and tolerability between the soft-gel capsules and the new tablet formulation of Kaletra which allows for fewer tablets per day and does not include additives possibly associated with increased diarrhea
Study MOO-267 PLATO a multi-center study evaluated and demonstrated improved quality of life when switching from other regimens efavirenz nevirapine indinavir and nelfinavir to Kaletra Instruments used to measure change in quality of life included the AIDS Clinical Trial Group ACTG Symptom Distress Module ASDM which measures the presence of bothersome symptoms commonly seen with HIV and ARV treatment the Medical Outcomes Study-HIV Health Survey MOS-HIV which is widely used to evaluate the Quality of Life QOL of HIV infected patients and the Center for Epidemiological Studies and Depression CES-D a validated self-reporting questionnaire used as a screening tool for depression
The hypothesis is that patients quality of life will improve when switched from Kaletra soft-gel to Kaletra tablets The tablet formulation of Kaletra will improve quality of life by simplifying current HAART regimens by decreasing pill count improving tolerability eliminating food restrictions and the need for drug refrigeration African-American subjects were selected for this study because they are an understudied population and due to adherence behavior In reviewing Abbott Study 418 and Study MOO 267 the percent of African-American enrollees accounted for 27 and 15 of the study groups respectively14 In studies where there is an association between socio demographic factors and adherence behavior the direction is consistent younger age non-white race lower income lower literacy and unstable housing was associated with non-adherence Adherence behavior refers to the extent to which patients take their medication as prescribed by their health provider As stated above patients who are younger non white race lower income and live in unstable housing are less likely to adhere to the prescribed medication regime It is important to evaluate antiretroviral therapy formulations to validate patient tolerability and acceptance in order to promote drug adherence This study will compare the tolerability and acceptance of patients on Kaletra soft-gel capsules with that of Kaletra tablet formulation utilizing validated instruments as described above
Kaletra has a long track record of being highly potent and not selective for protease inhibitor resistance as evidence by the Phase II Study 720 The results of this study demonstrate that ABT-378ritonavir therapy is highly potent durable and well tolerated when administered concomitantly with two nucleoside analog reverse transcriptase inhibitors to antiretroviral-naïve HIV-1 infected individuals A high proportion of subjects achieved normal viral suppression 50 copiesml - 78 by ITT No discontinuations due to study drug -related clinical or laboratory adverse events occurred during the first 48 weeks of study but the most common adverse effect was diarrhea 25 Given the high oleic content of the capsules dosing all six capsules at once may cause a bolus of this acid leading to increased diarrhea Because of the viral suppression advantages there is desire to see if there is a difference in quality of life and tolerability between the soft-gel capsules and the new tablet formulation of Kaletra which allows for fewer tablets per day and does not include additives possibly associated with increased diarrhea
Study MOO-267 PLATO a multi-center study evaluated and demonstrated improved quality of life when switching from other regimens efavirenz nevirapine indinavir and nelfinavir to Kaletra Instruments used to measure change in quality of life included the AIDS Clinical Trial Group ACTG Symptom Distress Module ASDM which measures the presence of bothersome symptoms commonly seen with HIV and ARV treatment the Medical Outcomes Study-HIV Health Survey MOS-HIV which is widely used to evaluate the Quality of Life QOL of HIV infected patients and the Center for Epidemiological Studies and Depression CES-D a validated self-reporting questionnaire used as a screening tool for depression
The hypothesis is that patients quality of life will improve when switched from Kaletra soft-gel to Kaletra tablets The tablet formulation of Kaletra will improve quality of life by simplifying current HAART regimens by decreasing pill count improving tolerability eliminating food restrictions and the need for drug refrigeration African-American subjects were selected for this study because they are an understudied population and due to adherence behavior In reviewing Abbott Study 418 and Study MOO 267 the percent of African-American enrollees accounted for 27 and 15 of the study groups respectively14 In studies where there is an association between socio demographic factors and adherence behavior the direction is consistent younger age non-white race lower income lower literacy and unstable housing was associated with non-adherence Adherence behavior refers to the extent to which patients take their medication as prescribed by their health provider As stated above patients who are younger non white race lower income and live in unstable housing are less likely to adhere to the prescribed medication regime It is important to evaluate antiretroviral therapy formulations to validate patient tolerability and acceptance in order to promote drug adherence This study will compare the tolerability and acceptance of patients on Kaletra soft-gel capsules with that of Kaletra tablet formulation utilizing validated instruments as described above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 371-11-05 | None | None | None |