Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318123
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2006-04-25
Brief Title:
Study to Evaluate the Effectiveness of ABC3TC EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Multicentre Open Label Prospective Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg Lamivudine 300 mg as QD Efavirenz 600 mg QD Versus Kaletra 400100 mg BID as Initial Antiretroviral Treatment
Status:
COMPLETED
Status Verified Date:
2008-01
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:
To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period
Detailed Description:
The efficacy of the highly active antiretroviral treatment HAART has been demonstrated in several clinical trials Even so a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice
Adherence to HAART treatment is critical to obtain lasting viral suppression Thus factors that are related to adherence such as high pill load or takes the complexity of the antiretroviral system tolerability and food restrictions may have an effect on viral replication
It has been demonstrated that simpler regimens with a scant number of tablets without food restrictions and with a single take a day are safe efficacious and that adherence improves
The combination of abacavir 600 mg lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence
Adherence to HAART treatment is critical to obtain lasting viral suppression Thus factors that are related to adherence such as high pill load or takes the complexity of the antiretroviral system tolerability and food restrictions may have an effect on viral replication
It has been demonstrated that simpler regimens with a scant number of tablets without food restrictions and with a single take a day are safe efficacious and that adherence improves
The combination of abacavir 600 mg lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence
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 |
|---|---|---|---|
| 2004-001282-18 | None | None | None |