Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162643
Status:
UNKNOWN
Last Update Posted:
2006-09-14
First Post:
2005-09-07
Brief Title:
PI Vs NNRTI Based Therapy for HIV Advanced Disease
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
Boosted PI VS NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
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:
Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts 200mm3
Detailed Description:
Current guidelines for initial therapy in HIV infection recommend 2 NRTIs plus either a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor NNRTI Recent data suggests that the rate of response to PI based therapy may be slightly compromised if the baseline CD4 count is 200mm3 and the plasma HIV-1-RNA 100000 copiesmL This may not be equally apparent if ritonavir boosted protease inhibitors are used The effect of baseline CD4 count and HIV-1-RNA levels on the antiviral efficacy of NNRTI based regimens has been less well characterized A significant number of patients currently initiate therapy at late stages of progression typically with baseline CD4 count is 200mm3 In Mexico approximately 60 of patients who initiate therapy are within this range of CD4 cell counts Currently the two combinations recommended as preferred are with two NRTIs and either Efavirenz or Lopinavirritonavir while other combinations of PIs and ritonavir are considered alternative
Comparison The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count 200mm3
Comparison The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count 200mm3
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