Hepatitis CPhase 4NCT00845676
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
A Phase 4 study testing Pegylated interferon alfa-2a + Ribavirin in people with Hepatitis C and Human Immunodeficiency Virus, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- Pegylated interferon alfa-2a + Ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly acquired HCV infection of 6 months or less duration
- Detectable HCV RNA at study entry
- HIV infection, any CD4 count
Who cannot join
- Pregnant or intent to become pregnant within 24 weeks of study completion
- Uncontrolled depression
- Other serious liver disease
- Other safety parameters must be met
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital/UCSF
San Francisco, California, 94110
About this study
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.
Read the detailed description
Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.
Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.
In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.
- Conditions
- Hepatitis C, Human Immunodeficiency Virus, HIV Infections
- Being tested
- Pegylated interferon alfa-2a + Ribavirin
- Keywords
- Hepatitis C virus, Acute hepatitis C infection, HIV, HCV
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2a + RibavirinDrug
Also called Pegasys, PEG-IFN, RBV
Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon alfa-2a + Ribavirin | Experimental | Pegylated interferon alfa-2a + Ribavirin Receives: Drug: Pegylated interferon alfa-2a + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR)
Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
Measured: 24 weeks
Secondary outcomes (2)
Safety and Tolerability of Treatment
Number of participants with treatment-associated problems
Measured: 48 weeks
Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionDec 2013
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.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- California HIV/AIDS Research Program
- Responsible party
- Sponsor
- Investigators
- Brad Hare, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845676
- Sponsor's protocol ID
- CHRP ID06-SF-218
- Status last verified
- May 2020
- First submitted
- 17 Feb 2009
- Last updated
- 18 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Hepatitis C Virus in HIV Co-Infection
- ClinicalTrials.gov ID
- NCT00845676
- Acronym / sponsor ID
- CHRP ID06-SF-218
- Conditions
- Hepatitis C, Human Immunodeficiency Virus, HIV Infections
- Keywords
- Hepatitis C virus, Acute hepatitis C infection, HIV, HCV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- California HIV/AIDS Research Program
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.
Detailed description
Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.
Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.
In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon alfa-2a + Ribavirin | Experimental | Drug: Pegylated interferon alfa-2a + RibavirinPegylated interferon alfa-2a + Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly acquired HCV infection of 6 months or less duration
- Detectable HCV RNA at study entry
- HIV infection, any CD4 count
Key exclusion criteria (4 listed)
- Pregnant or intent to become pregnant within 24 weeks of study completion
- Uncontrolled depression
- Other serious liver disease
- Other safety parameters must be met
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 |
|---|---|---|
| Pegylated interferon alfa-2a + RibavirinAlso: Pegasys, PEG-IFN, RBVPegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks | Drug | Pegylated interferon alfa-2a + Ribavirin |
Primary outcome
Sustained Virologic Response (SVR)
Time frame: 24 weeks
Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
2 secondary outcomes
Safety and Tolerability of Treatment
Time frame: 48 weeks
Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Home page of the Positive Health Program, UCSF HIV/AIDS Division at San Francisco General HospitalLink provided by the sponsor.
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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.
Brad Hare, MD principal investigator
University of California, San Francisco
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 Pegylated interferon alfa-2a + Ribavirin in people with Hepatitis C and Human Immunodeficiency Virus, run by University of California, San Francisco 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 3 inclusion and 4 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 18 May 2020. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2013). 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?
Sustained Virologic Response (SVR) (time frame: 24 weeks). 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 18 May 2020.