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Viral Hepatitis CPhase 2NCT02125500

Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection

A Phase 2 study testing Sofosbuvir/Ledipasvir fixed dose in people with Viral Hepatitis C and HIV, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

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

Official record
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Trial summary

Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Viral Hepatitis C, HIV
What is being tested?
Sofosbuvir/Ledipasvir fixed dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteFrance
Study dates
Aug 2014to Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Confirmed HIV infection
  • Infection with HCV genotype 1 only, confirmed at screen visit, with a HCV-RNA ≥ 1000 InternationalUnit(IU)/mL at screen visit
  • Treatment-experienced subjects with:
  • previous virological failure to tritherapy with Peginterferon/Ribavirin and protease inhibitor,
  • or premature discontinuation of previous tritherapy with Peginterferon/Ribavirin and protease inhibitor due to intolerance to Peginterferon or protease inhibitor
  • Anti-HCV treatment stopped for at least the last 3 months
Show all 34Show fewer
  • Patients on a stable (for more than 1 month) antiretroviral treatment consisting of an emtricitabine/tenofovir or lamivudine/tenofovir standard of care backbone plus efavirenz or raltegravir or rilpivirine or enfuvirtide. Alternative combinations of the above listed medications may be allowed.
  • Dendritic cells 4 > 100/mm3 and > 15% at screen visit
  • HIV-RNA < 50cp/ml for more than 3 months at screen visit
  • Any liver fibrosis grade, with the assessment of the presence or not of cirrhosis at screening, cirrhosis being defined as a METAVIR score of F4 on the liver puncture biopsy and/or with hepatic impulse elastometry ≥ 14,5 kilopascal (kPa):
  • Previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4),
  • and/or significant liver biopsy (cumulative length ≥ 15mm or ≥ 5 portal spaces), within the past 18 months
  • and/or significant and reliable liver stiffness assessment (Fibroscan®) within the past 6 months (at least 10 measures with IQR less than 30% of the median value and a success rate of at least 70%).
  • Female patients with child-bearing potential, and their heterosexual partners must use adequate contraception from the date of screening until 90 days after administration of the last dose of study drug. Male participants must agree to consistently and correctly use a condom, while their female partner must use adequate contraception from the date of screening until 90 days after administration of the last dose of study drug
  • Body weight ≥40 kg and ≤125 kg
  • Informed and signed consent for the main study and the Pharmacokinetic (PK ) sub-study (for the participating patients)
  • Patients with Health insurance
  • Non inclusion Criteria:
  • Child-Pugh B or C cirrhosis or history of decompensated cirrhosis.
  • Co-infection with Hepatitis B virus (HBV) (AgHBs +) with HBV DNA > 1000 UI/ml
  • Pregnant or breast-feeding women
  • Transplant recipients
  • Opportunistic infections (stage C), active or occurred within 6 months prior to baseline
  • Evolutive malignancy, including hepatocarcinoma which should be controlled prior to baseline
  • Alcohol or drug consumption which may affect the study participation according to the investigator. Patients included in a programme of substitution with methadone or buprenorphine could be enrolled. The opinion of a consultant in addictology is recommended for patients presenting with current drug use or drug use during the previous year.
  • Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable
  • Patients participating in another clinical trial within 30 days prior to inclusion
  • Hb < 10 g/dL (female) or < 11g/dL (male)
  • Platelets < 50 000/mm3
  • Neutrophil count < 750/mm3
  • Renal failure defined as creatinin clearance (MDRD) < 60ml/min
  • Other antiretroviral drugs than those allowed in the study
  • Contra-indications to Sofosbuvir, Ledipasvir
  • Contra-indicated treatment likely to interfere with the study drugs as listed in the protocol

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Méthodologie et de Gestion de Rennes

    Rennes

Other trials in France

About this study

Official title: Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir (GS-5885) Fixed-dose Combination in NS3/4A Protease Inhibitor-experienced Subjects With HCV Genotype 1 Infection and HIV Co-infection

Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.

Being tested
Sofosbuvir/Ledipasvir fixed dose
Keywords
HCV/HIV coinfection, HCV genotype 1
Medical subject headings
Hepatitis C

What participants receive

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

  • Sofosbuvir/Ledipasvir fixed doseDrug

    Also called Sofosbuvir is also known as GS-7977 or PSI-7977., Ledipasvir is also known as GS-5885.

    SOF 400 mg/LDV 90 mg FDC tablet administered orally once daily

Study groups in NCT02125500
Study groupRoleWhat they receive
Sofosbuvir/LedipasvirExperimentalNon-cirrhotic patients will receive SOF/LDV Fixed Dose Combination (FDC) for 12 weeks. Cirrhotic patients will receive SOF/LDV Fixed Dose Combination (FDC) for 24 weeks.
Receives: Drug: Sofosbuvir/Ledipasvir fixed dose

What is being measured

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

  1. Sustained virologic response 12 weeks after discontinuation of therapy (SVR12), i.e. at week 36.

    Measured: 12 weeks post-treatment

Secondary outcomes (8)

  1. Adverse clinical and biological events that occur during the treatment and up to 24 weeks after the end of the treatment

    Measured: up to 24 weeks after the end of the treatment

  2. Number and causes of poor adherence and treatment interruptions

    Measured: at 1,2,3,4,8,12,16, 20, 24 weeks during treatment, 4, 8,14,18,24 weeks after treatment discontinuationeeks after discontinuation of drugs

  3. SVR rate 24 weeks (i.e. W48) after the end of treatment and according to the HCV sub-type

    Measured: Week 48

  4. Number of patients with HCV resistance mutations to Sofosbuvir and/or Ledipasvir

    Measured: from Day(D)0 to Week (W)24

  5. HCV viral load

    Measured: at Day 0, Week 1, 2, 4, 8, 12, 16, 20, week 24, and 4, 8, 12, 18 and 24 weeks after the end of the treatment

  6. Plasma HIV RNA levels

    Measured: at Day 0, Week 4, 8, 12, 16, 20, 24, 36 and Week 48

  7. Assess drug-drug interactions between HCV et HIV drugs

    Describe pharmacokinetic parameters of HIV drugs at Day 0 and Week 4 Describe pharmacokinetic parameters of Sofosbuvir and Ledipasvir at Week 4

    Measured: Day 0 and Week 4

  8. Patient's reported outcomes evaluation

    Measured: Day 0, Week 12, Week 24 and Week 36

Timeline

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

  1. First posted29 Apr 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02125500
Sponsor's protocol ID
ANRS HC31 SOFTRIH
Status last verified
Jun 2017
First submitted
24 Apr 2014
Last updated
29 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir/Ledipasvir fixed dose in people with Viral Hepatitis C and HIV, run by ANRS, Emerging Infectious Diseases at 1 site in France.

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 34 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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sustained virologic response 12 weeks after discontinuation of therapy (SVR12), i.e. at week 36. (time frame: 12 weeks post-treatment). 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 NCT02125500.

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 29 Jun 2017.

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