Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03394196 |
Other study ID # |
STUDY00000228 |
Secondary ID |
R01AI120765 |
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 4, 2018 |
Est. completion date |
May 31, 2020 |
Study information
Verified date |
January 2021 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance
informed 2nd-line ARV implementation study.
Description:
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance
informed 2nd-line ARV implementation study.
DURATION
Up to 3 years
SAMPLE SIZE
150
POPULATION
HIV-2-infected adults (≥18 years old); ARV-experienced, with virologic failure on 1st-line
2NRTI+LPV/r in the ISAARV program.
STRATIFICATION
By ARV resistance
REGIMEN OR INTERVENTION
Intervention: Implement real time ARV resistance testing using rapid DBS/CS ARV Regimens:
Based on ARV resistance testing
1. No resistance: Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF
300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg
BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) +Enhanced Adherence Counseling
2. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg
QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC +
LPV/r + RAL) + Enhanced Adherence Counseling
3. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD
+ Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID + Raltegravir 400mg
BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling