Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444379
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2007-03-06
Brief Title:
Anti-Retrovirals for Kaposis Sarcoma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Comparison of Protease Inhibitor-based Versus Non-nucleoside Reverse Transcriptase Inhibitor-based Antiretroviral Therapy for Initial Treatment of Individuals With AIDS-related Kaposis Sarcoma in Sub-Saharan Africa
Status:
COMPLETED
Status Verified Date:
2014-08
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:
ARKS
Brief Summary:
The primary purpose of this study is to determine whether a protease inhibitor-based antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in persons with AIDS-related KS in Africa
Detailed Description:
With the advent of the HIV epidemic Kaposis sarcoma KS is now the most common adult cancer in many parts of sub-Saharan Africa In HIV-infected patients with KS in developed settings the initiation of highly active anti-retroviral therapy HAART has been associated with regression of the tumor in many but not all cases even in the absence of conventional chemotherapy However it is not known which specific antiretroviral drugs or regimens are critical to convey HAARTs anti-KS effect In particular it is not known whether the anti-KS effects of protease inhibitors PI in vitro and in animal models translate into improved clinical outcomes as compared to non-PI-based HAART regimens To address this we will determine whether a PI-based HAART regimen lopinavirritonavir plus emtricitabinetenofovir is superior to a non-nucleoside reverse transcriptase inhibitor NNRTI-based HAART regimen efavirenz plus emtricitabinetenofovir in promoting the regression of KS tumor burden in persons with AIDS-related KS in sub-Saharan Africa We will enroll 224 patients with AIDS-related KS in Kampala Uganda randomly assign them to either a PI-based HAART or an NNRTI-based HAART regimen and observe them for one year to determine the response in their KS to therapy
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