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HIV-1 InfectionPhase 3Co-STARsNCT02707601

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

A Phase 3 study testing E/C/F/TAF, F/R/TAF and LDV/SOF in people with HIV-1 Infection and HCV Infection, run by Gilead Sciences at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection, HCV Infection
What is being tested?
E/C/F/TAF, F/R/TAF and LDV/SOF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
43 sitesin 2 countries
Study dates
1 Apr 2016to 29 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States42 sites

  • Lehigh Valley Health Network, Network Office of Research and Innovation

    Allentown, Pennsylvania

  • Clinical Alliance for Research & Education

    Annandale, Virginia

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia

  • Emory University

    Atlanta, Georgia

  • Central Texas Clinical Research

    Austin, Texas

  • Be Well Medical Center

    Berkley, Michigan

  • University of Alabama at Birmingham

    Birmingham, Alabama

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina

  • The CORE Foundation

    Chicago, Illinois

  • Community AIDS Network

    Clearwater, Florida

  • UT Southwestern Medical Center

    Dallas, Texas

  • Duke University

    Durham, North Carolina

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida

  • Therafirst Medical Center

    Fort Lauderdale, Florida

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida

  • East Carolina University

    Greenville, North Carolina

  • Gordon E. Crofoot MD PA

    Houston, Texas

  • Therapeutics Concepts, PA

    Houston, Texas

  • Kansas City Free Health Clinic

    Kansas City, Missouri

  • Mills Clinical Research

    Los Angeles, California

  • Peter J Ruane MD Inc

    Los Angeles, California

  • University of Miami

    Miami, Florida, 33136

  • AIDS Healthcare Foundation

    Miami, Florida

  • AIDS Healthcare Foundation

    Miami Beach, Florida

  • Weill Cornell Medical College

    New York, New York

  • Saint Michael's Medical Center

    Newark, New Jersey

  • Orlando Immunology Center

    Orlando, Florida

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Spectrum Medical Group

    Phoenix, Arizona

  • University of California Davis

    Sacramento, California

  • University of California San Diego

    San Diego, California

  • Kaiser Permanente

    San Francisco, California

  • Chatham County Health Department

    Savannah, Georgia

  • Peter Shalit MD

    Seattle, Washington

  • Southern Cal

    Spokane, Washington

  • Community Health Care

    Tacoma, Washington

  • St. Josephs Comprehensive Research Institute

    Tampa, Florida

  • The George Washington University Medical Center

    Washington D.C., District of Columbia

  • Whitman-Walker Health

    Washington D.C., District of Columbia

  • Triple O Research Institute PA

    West Palm Beach, Florida

  • Rowan Tree Medical PA

    Wilton Manors, Florida

Other trials in United States

Puerto Rico1 site

  • Clinical Research Puerto Rico Inc

    San Juan

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
E/C/F/TAF, F/R/TAF, LDV/SOF
Keywords
HIV, HCV, Antiretroviral therapy, HCV direct acting antiviral(s) (DAA)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E/C/F/TAFDrug

    Also called Genvoya®

    150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily

  • F/R/TAFDrug

    Also called Odefsey®

    200/25/25 mg FDC tablet administered orally once daily

  • LDV/SOFDrug

    Also called Harvoni®, GS-5885/GS-7977

    90/400 mg FDC tablet administered orally once daily

Study groups in NCT02707601
Study groupRoleWhat they receive
E/C/F/TAF + LDV/SOFExperimentalPart 1: Participants will switch from 2 nucleoside reverse transcriptase inhibitors (NRTI) plus a third agent to E/C/F/TAF. Part 2: After 8 weeks of E/C/F/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.
Receives: Drug: E/C/F/TAF; Drug: LDV/SOF
F/R/TAF + LDV/SOFExperimentalPart 1: Participants will switch from 2 NRTI plus a third agent to F/R/TAF. Part 2: After 8 weeks of F/R/TAF treatment, the participants maintaining HIV-1 RNA < 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.
Receives: Drug: F/R/TAF; Drug: LDV/SOF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)

    Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.

    Measured: HCV Posttreatment Week 12

Secondary outcomes (3)

  1. Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)

    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment.

    Measured: HCV Posttreatment Week 4

  2. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Measured: 24 weeks after start of HIV treatment

  3. Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment

    Measured: Up to 32 weeks plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2016 (estimated)
  2. Study start1 Apr 2016
  3. Primary completion14 Sep 2017
  4. Study completion29 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02707601
Sponsor's protocol ID
GS-US-366-1992
Other IDs
2014-004545-27, 2014
Acronym
Co-STARs
Status last verified
Sep 2018
First submitted
9 Mar 2016
Last updated
14 Nov 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster LB-12]. AASLD: The Liver Meeting 2017 20-24 October; Washington DC.

  • Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster PE16/52]. European AIDS Conference 2017 25-27 October; Milan Italy.

  • Huhn GD, Ramgopal M, Jain MK, Hinestrosa F, Asmuth DM, Slim J, Goldstein D, Applin S, Ryu JH, Jiang S, Cox S, Das M, Nguyen-Cleary T, Piontkowsky D, Guyer B, Rossaro L, Haubrich RH. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens. PLoS One. 2020 Jan 29;15(1):e0224875. doi: 10.1371/journal.pone.0224875. eCollection 2020.

    PubMed 31995556

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF, F/R/TAF and LDV/SOF in people with HIV-1 Infection and HCV Infection, run by Gilead Sciences at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) (time frame: HCV Posttreatment Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02707601, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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