Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
Status: | Completed |
---|---|
Conditions: | Infectious Disease, HIV / AIDS, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/16/2018 |
Start Date: | April 1, 2016 |
End Date: | September 29, 2017 |
A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens)
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and
tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
(E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current
antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected
participants.
tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
(E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current
antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected
participants.
Key Inclusion Criteria:
- Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female
individuals, without cirrhosis, treatment-naive or treatment-experienced with
interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).
- Compensated cirrhotic individuals must be HCV treatment-naive.
- No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except
boceprevir, telaprevir and simeprevir, in combination with IFN and RBV
- Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior
to screening.
- Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level
according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL,
single values ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is
allowed.
- For individuals with 3 or more prior ARV regimens, a regimen history should be
provided for approval by the Sponsor.
- Note: Individuals that changed from TDF to TAF less than 6 months ago will be
eligible as long as the TDF/ TAF change was the only change to the regimen.
- Plasma HIV-1 RNA level < 50 copies/mL at the screening visit
- Have no documented resistance to any of the HIV study agents at time in the past,
including but not limited to the reverse transcriptase resistance mutations K65R,
K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L,
the combination of K103N+L100I, or 3 or more thymidine analog associated mutations
(TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F,
K219Q/E/N/R). If a historical genotype prior to first ARV is not available or
individual had 3 or more prior ARV regimens, individual will have proviral genotype
analysis for archived resistance prior to Day 1.
- No history of HIV virologic failure
- No evidence of Hepatitis B infection
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by
Cockcroft-Gault formula
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
43
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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University of Miami A private research university with more than 15,000 students from around the...
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Allentown, Pennsylvania 18102
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of California-Davis As we begin our second century, UC Davis is poised to become...
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