Hepatitis C InfectionPhase 4NCT02220868
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
A Phase 4 study testing Sofosbuvir, Ribavirin, and Stribild in people with Hepatitis C Infection and HIV Infection, run by Saint Michael's Medical Center at 1 site in United States.
Trial summary
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis C Infection, HIV Infection
- What is being tested?
- Sofosbuvir, Ribavirin, and Stribild
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2015
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Chronic HCV genotype 1 infection
- Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
- CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks
- HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous 12 weeks
Who cannot join
- History of integrase inhibitor resistance
- History of integrase inhibitor failure
- Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3
- Patients with cirrhosis
- Platelet count under 90,000 per cubic millimeter
- Hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
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- Previous treatment with a DAA
- Hepatocellular carcinoma
- AFP>100 ng/mL
- hepatitis B virus (HBsAg positive)
- Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Michael's Medical Center
Newark, New Jersey, 07102
About this study
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.
Read the detailed description
The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
- Conditions
- Hepatitis C Infection, HIV Infection
- Being tested
- Sofosbuvir, Ribavirin, and Stribild
- Keywords
- HIV, HCV, DAA
- Medical subject headings
- Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir, Ribavirin, and StribildDrug
| Study group | Role | What they receive |
|---|---|---|
| Sofossbuvir, Riabvirin, Stribild | Other | Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild Receives: Drug: Sofosbuvir, Ribavirin, and Stribild |
What is being measured
The primary outcome is the main question the study is designed to answer.
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
patients who have achieved non-detectable HCV levels 12 weeks post treatment
Measured: 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Michael's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihad Slim, MD, Saint Michael's Medical Center
- Investigators
- Jihad Slim, MD, Principal investigator, Saint Michael's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220868
- Sponsor's protocol ID
- IN-US-334-1527
- Status last verified
- Nov 2015
- First submitted
- 18 Aug 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
- ClinicalTrials.gov ID
- NCT02220868
- Acronym / sponsor ID
- IN-US-334-1527
- Conditions
- Hepatitis C Infection, HIV Infection
- Keywords
- HIV, HCV, DAA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saint Michael's Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.
Detailed description
The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofossbuvir, Riabvirin, Stribild | Other | Drug: Sofosbuvir, Ribavirin, and StribildOpen-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Chronic HCV genotype 1 infection
- Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
- CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks
- HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous 12 weeks
Key exclusion criteria (11 listed)
- History of integrase inhibitor resistance
- History of integrase inhibitor failure
- Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3
- Patients with cirrhosis
- Platelet count under 90,000 per cubic millimeter
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 |
|---|---|---|
| Sofosbuvir, Ribavirin, and Stribild | Drug | Sofossbuvir, Riabvirin, Stribild |
Primary outcome
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
Time frame: 12 weeks post treatment
patients who have achieved non-detectable HCV levels 12 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
Jihad Slim, MD principal investigator
Saint Michael's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir, Ribavirin, and Stribild in people with Hepatitis C Infection and HIV Infection, run by Saint Michael's Medical Center at 1 site 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 5 inclusion and 11 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 4 Aug 2016. 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 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?
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?
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy (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?
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 4 Aug 2016.