Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336778
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2006-06-12
Brief Title:
Phase 1 Pilot Study of an ART Bridging Regimen in Highly Experienced Patients Unable to Achieve Viral Suppression
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase I Pilot Study Of An Antiretroviral Bridging Regimen In Highly Experienced Patients Unable To Achieve Viral Suppression
Status:
COMPLETED
Status Verified Date:
2021-05
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:
We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an option to consider in patients with MDR HIV
This strategy will provide them with the bridge they desperately need so that they can await the development of new therapies that when used in combination will give them the best chance in achieving complete virologic suppression
This strategy will provide them with the bridge they desperately need so that they can await the development of new therapies that when used in combination will give them the best chance in achieving complete virologic suppression
Detailed Description:
Bridge is a pilot single-arm open-label study to assess the ability of 3 FDA approved anti-retroviral drugs to decrease replication capacity of HIV virus in order to stabilize CD4 cell count and HIV RNA viral loads All subjects will be prescribed the three-drug combination of lamivudine 3TC tenofovir disoproxil fumarate TDF nelfinavir NLVThe Bridge Study is a pilot study to assess the ability of 3 FDA approved anti-retroviral drugs to decrease replication capacity of HIV virus in order to stabilize CD4 cell count and HIV RNA viral loads All subjects will receive the three-drug combination of lamivudine 3TCtenofovir disoproxil fumarateTDFnelfinavir NLV
The study will enroll 12 subjects for a 48 week study Major entry criteria include HIV Men and women 18 years of age who are currently failing antiretroviralARVtherapy with an HIV-1 RNA VL 10000 and have failed multiple treatment regimens due to resistance andor intolerance Genotype must demonstrate resistance to 3 major classes of ARVs - PIs NNRTIs and NRTIs
The study will enroll 12 subjects for a 48 week study Major entry criteria include HIV Men and women 18 years of age who are currently failing antiretroviralARVtherapy with an HIV-1 RNA VL 10000 and have failed multiple treatment regimens due to resistance andor intolerance Genotype must demonstrate resistance to 3 major classes of ARVs - PIs NNRTIs and NRTIs
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