HCV HIVPhase 4NCT02339038
Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
A Phase 4 study testing Ledipasvir 90 mg and Sofosbuvir 400 mg in people with HCV HIV, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
Background: Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HCV HIV
- What is being tested?
- Ledipasvir 90 mg and Sofosbuvir 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2015to 13 Jul 2018
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age at time of screening who is determined to be eligible based on evaluation by a treating provider,
- Documentation of genotype 1 (GT-1) infection, liver fibrosis staging by any AASLD/IDSA guideline approved measurement, and HIV status determination.
- Chronic HCV genotype-1 infection prior to study enrollment. Chronic HCV-infection is defined as the following: positive for anti-HCV Ab or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening
- Compensated liver disease, both with and without cirrhosis, as determined clinically by referring provider
- If coinfected with HIV, stable HIV disease as determined by a treating provider
- Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
Who cannot join
- Women who are pregnant or breastfeeding
- Screening laboratory analyses showing any of the following abnormal laboratory results:
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min as estimated by the Modification of Diet in Renal Disease (MDRD) equation (utilized by LabCorp):
- eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)
- Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
- Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Unity Health Care, Inc./DC General
Washington D.C., District of Columbia, 20002
Family Medical and Conseling Services
Washington D.C., District of Columbia, 20020
About this study
Official title: A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
Background:
- Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia.
Read more
Objectives:
- To see if people can be treated for Hepatitis C safely and successfully in community-based health centers.
Eligibility:
- Adults who need treatment for chronic Hepatitis C infection.
Design:
- Participants will be screened with blood tests. Their current medicines will be reviewed.
- Participants will give researchers access to their medical records. Researchers will follow participants through these records.
- Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits.
- Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly.
- Participants will have monthly follow-up visits for up to 3 months after they finish their medicine.
- Participants will have yearly follow-up visits with their care provider for up to 10 years.
Read the detailed description
Treatment for hepatitis C has been revolutionized in the last 2 years with the advent of combination antiviral therapy yielding high cure rates; although, the long term effects of treatment remain uncertain. Use of these medications has been limited to clinical trial settings typically by highly specialized care teams in tertiary care hospitals. As the prevalence of hepatitis C is significant, there exists a significant imbalance between patients who require treatment and specialists who provide treatment. Success rates in treatment of hepatitis C by primary care doctors or physician extenders, such as nurse practitioners or physician assistants, is largely unknown.
As such, we propose the first community-based, large scale, longitudinal study of directly acting antiviral (DAA)-based treatment for chronic hepatitis C, set in the District of Columbia. Within this study, approximately 600 HCV genotype 1 monoinfected and HCV/HIV coinfected subjects will be treated with ledipasvir/sofosbuvir (90 mg/400 mg) fixed dosed combination for 8-24 weeks, based on the medication labeling instructions, and followed for both immediate (SVR12) and long term (comorbid disease, cirrhosis, hepatocellular carcinoma, transplantation and mortality) outcomes over a 10 year study period. The study will be conducted exclusively in the District of Columbia clinics associated with the NIH DC Partnership for AIDS/HIV Progress (DC PFAP), which serves a population comprised primarily of minorities, with a high degree of negative predictors of treatment response. In this study, participants will be assigned to treatment either by (1) an ID or hepatology specialist, (2) primary care provider, or (3) physician extender. Please see Figure 1 study schema for an approximate distribution of subjects. Each of these provider groups will undergo uniform training on treatment of hepatitis C and management of adverse events prior to initiation of study. All subjects will sign informed consent and agree to treatment and follow up phases of the study. During the course of the study, subjcts will be clinically evaluated based on American Association for the Study of Liver Diseases (AASLD)/ the Infectious Diseases Society of America (IDSA) guidelines for the management of hepatitis C. Clinical data from subjects will be captured in a city wide cohort database, which will store guideline-driven data points from each clinic visit within the network.
Through this trial we will explore the efficacy of managing hepatitis C subjects with directly acting antiviral therapy in an urban, community-based setting, and investigate the effect of provider type (specialist, primary care, or physician extender) on treatment outcome. We will detail the safety and tolerability of this treatment. We will assess variability in treatment outcomes between monoinfected and HIV-coinfected subjects. Finally, we will evaluate the public health impact of large-scale treatment of HCV infected subjects in preventing long-term clinical outcomes. As the first interferon (IFN)- and ribavirin (RBV)-free, urban community-based treatment utilizing new standard of care criteria, this study will serve as a model for implementation of similar practice patterns globally.
- Conditions
- HCV HIV
- Being tested
- Ledipasvir 90 mg and Sofosbuvir 400 mg
- Keywords
- Community Based Research, Hepatitis C Virus and Human Immunodeficiency Virus, Ledipasvir/Sofosbuvir, Fixed Dose Combination, Sustained Viral Response
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledipasvir 90 mg and Sofosbuvir 400 mgDrug
Also called Harvoni
Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Standard of care treatment using Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination by mouth daily for 2, 3, or 6 months Receives: Drug: Ledipasvir 90 mg and Sofosbuvir 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).
Measured: At least 12 weeks after completion of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study start7 Jan 2015
- Primary completion15 Jun 2016
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HCV HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Henry Masur, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339038
- Sponsor's protocol ID
- 15N064
- Other IDs
- 15-CC-N064, 999915064
- Status last verified
- Jun 2017
- First submitted
- 14 Jan 2015
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
PubMed 23172780Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014 Mar 4;160(5):293-300. doi: 10.7326/M13-1133.
PubMed 24737271Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24.
PubMed 22534149Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, Akoth E, Thomas A, Ahmed C, Espinosa M, Price A, Rosenthal E, Tang L, Wilson E, Bentzen S, Masur H, Kottilil S; ASCEND Providers. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. 2017 Sep 5;167(5):311-318. doi: 10.7326/M17-0118. Epub 2017 Aug 8.
PubMed 28785771
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
- ClinicalTrials.gov ID
- NCT02339038
- Acronym / sponsor ID
- 15N064
- Conditions
- HCV HIV
- Keywords
- Community Based Research, Hepatitis C Virus and Human Immunodeficiency Virus, Ledipasvir/Sofosbuvir, Fixed Dose Combination, Sustained Viral Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 7 Jan 2015
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia.
Objectives:
- To see if people can be treated for Hepatitis C safely and successfully in community-based health centers.
Eligibility:
- Adults who need treatment for chronic Hepatitis C infection.
Design:
- Participants will be screened with blood tests. Their current medicines will be reviewed.
- Participants will give researchers access to their medical records. Researchers will follow participants through these records.
- Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits.
- Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly.
- Participants will have monthly follow-up visits for up to 3 months after they finish their medicine.
- Participants will have yearly follow-up visits with their care provider for up to 10 years.
Detailed description
Treatment for hepatitis C has been revolutionized in the last 2 years with the advent of combination antiviral therapy yielding high cure rates; although, the long term effects of treatment remain uncertain. Use of these medications has been limited to clinical trial settings typically by highly specialized care teams in tertiary care hospitals. As the prevalence of hepatitis C is significant, there exists a significant imbalance between patients who require treatment and specialists who provide treatment. Success rates in treatment of hepatitis C by primary care doctors or physician extenders, such as nurse practitioners or physician assistants, is largely unknown.
As such, we propose the first community-based, large scale, longitudinal study of directly acting antiviral (DAA)-based treatment for chronic hepatitis C, set in the District of Columbia. Within this study, approximately 600 HCV genotype 1 monoinfected and HCV/HIV coinfected subjects will be treated with ledipasvir/sofosbuvir (90 mg/400 mg) fixed dosed combination for 8-24 weeks, based on the medication labeling instructions, and followed for both immediate (SVR12) and long term (comorbid disease, cirrhosis, hepatocellular carcinoma, transplantation and mortality) outcomes over a 10 year study period. The study will be conducted exclusively in the District of Columbia clinics associated with the NIH DC Partnership for AIDS/HIV Progress (DC PFAP), which serves a population comprised primarily of minorities, with a high degree of negative predictors of treatment response. In this study, participants will be assigned to treatment either by (1) an ID or hepatology specialist, (2) primary care provider, or (3) physician extender. Please see Figure 1 study schema for an approximate distribution of subjects. Each of these provider groups will undergo uniform training on treatment of hepatitis C and management of adverse events prior to initiation of study. All subjects will sign informed consent and agree to treatment and follow up phases of the study. During the course of the study, subjcts will be clinically evaluated based on American Association for the Study of Liver Diseases (AASLD)/ the Infectious Diseases Society of America (IDSA) guidelines for the management of hepatitis C. Clinical data from subjects will be captured in a city wide cohort database, which will store guideline-driven data points from each clinic visit within the network.
Through this trial we will explore the efficacy of managing hepatitis C subjects with directly acting antiviral therapy in an urban, community-based setting, and investigate the effect of provider type (specialist, primary care, or physician extender) on treatment outcome. We will detail the safety and tolerability of this treatment. We will assess variability in treatment outcomes between monoinfected and HIV-coinfected subjects. Finally, we will evaluate the public health impact of large-scale treatment of HCV infected subjects in preventing long-term clinical outcomes. As the first interferon (IFN)- and ribavirin (RBV)-free, urban community-based treatment utilizing new standard of care criteria, this study will serve as a model for implementation of similar practice patterns globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Drug: Ledipasvir 90 mg and Sofosbuvir 400 mgStandard of care treatment using Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination by mouth daily for 2, 3, or 6 months |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding
- Screening laboratory analyses showing any of the following abnormal laboratory results:
- eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)
- Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
- Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ledipasvir 90 mg and Sofosbuvir 400 mgAlso: HarvoniLedipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines | Drug | Standard of Care |
Primary outcome
Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
Time frame: At least 12 weeks after completion of medication
The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23172780Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
- Background: PubMed 24737271Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014 Mar 4;160(5):293-300. doi: 10.7326/M13-1133.
- Background: PubMed 22534149Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24.
- Derived from this study: PubMed 28785771Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, Akoth E, Thomas A, Ahmed C, Espinosa M, Price A, Rosenthal E, Tang L, Wilson E, Bentzen S, Masur H, Kottilil S; ASCEND Providers. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. 2017 Sep 5;167(5):311-318. doi: 10.7326/M17-0118. Epub 2017 Aug 8.
- Individual participant dataSharing planned: No
Related trials for HCV HIV
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Active, not recruiting
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
RecruitingObservational study
Rapid HIV, Hep C, and Syphilis Screening in a Rural Street Medicine Clinic
HIV Testing, HEPATITIS C (HCV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Masur, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ledipasvir 90 mg and Sofosbuvir 400 mg in people with HCV HIV, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
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 6 inclusion and 6 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 12 Jul 2017). 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?
Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs (time frame: At least 12 weeks after completion of medication). 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 NCT02339038, which also lists 4 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 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.