HIV/HCV CoinfectionPhase 3NCT02762383
Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)
A Phase 3 study testing Peginterferon Alfa-2 in people with HIV/HCV Coinfection, run by Hoffmann-La Roche at 10 sites in Belgium.
Trial summary
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/HCV Coinfection
- What is being tested?
- Peginterferon Alfa-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 10 sitesBelgium
- Study dates
- Mar 2005to Jun 2009
- Phase
- Phase 3
- 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
- Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
- Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
- Detectable serum HCV RNA at Screening
- Serologic evidence of HIV infection by HIV RNA detection
- CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
- Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
- Compensated liver disease
- No evidence of hepatocellular carcinoma
Who cannot join
- Pregnant or breastfeeding
- Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
- Any investigational drug within 6 weeks prior to first dose
- Positive for hepatitis A immunoglobulin M antibody
- Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
- Severe psychiatric or neurologic comorbidity
Show all 10Show fewer
- History of any significant medical conditions, such as immune disorders or disease of the major organ systems
- Uncontrolled thyroid disease
- Severe retinopathy
- Evidence of drug abuse
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
Study site
Brussels, 1000
Study site
Brussels, 1020
Study site
Brussels, 1070
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Charleroi, 6000
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Liège, 4000
About this study
Official title: A Pilot, Open-Label, Multicentre Study Evaluating the Long-Term Safety and Tolerability of a Low-Dose Peginterferon Alfa-2a Maintenance Monotherapy in Chronic Hepatitis C Patients Co-Infected With Human Immunodeficiency Virus and Who Do Not Respond to a Standard Regimen of Peginterferon Alfa-2a Plus Ribavirin
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.
- Conditions
- HIV/HCV Coinfection
- Being tested
- Peginterferon Alfa-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Alfa-2Drug
Also called Pegasys
Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Alfa-2a | Experimental | Participants will receive a low dose of peginterferon alfa-2a for 18 months. Receives: Drug: Peginterferon Alfa-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: From Baseline to end of treatment (up to 18 months)
Secondary outcomes (6)
Percentage of Participants with Histological Response According to Paired Biopsy
Measured: At end of treatment (up to 18 months)
HIV RNA Viral Load in Copies per Milliliter (copies/mL)
Measured: At end of treatment (up to 18 months)
Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL)
Measured: At end of treatment (up to 18 months)
Percentage of Participants with Virological Response According to HCV RNA Viral Load
Measured: At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall)
Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level
Measured: At end of treatment (up to 18 months)
Percentage of Participants with Sustained Biochemical Response According to ALT Level
Measured: At 24 weeks after end of treatment (up to 2 years overall)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2005
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/HCV CoinfectionStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762383
- Sponsor's protocol ID
- ML18234
- Other IDs
- 2004-002736-26, 2004
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Multicentre Study Evaluating the Long-Term Safety and Tolerability of a Low-Dose Peginterferon Alfa-2a Maintenance Monotherapy in Chronic Hepatitis C Patients Co-Infected With Human Immunodeficiency Virus and Who Do Not Respond to a Standard Regimen of Peginterferon Alfa-2a Plus Ribavirin
- ClinicalTrials.gov ID
- NCT02762383
- Acronym / sponsor ID
- ML18234
- Conditions
- HIV/HCV Coinfection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 May 2016 (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.
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Alfa-2a | Experimental | Drug: Peginterferon Alfa-2Participants will receive a low dose of peginterferon alfa-2a for 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
- Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
- Detectable serum HCV RNA at Screening
- Serologic evidence of HIV infection by HIV RNA detection
- CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding
- Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
- Any investigational drug within 6 weeks prior to first dose
- Positive for hepatitis A immunoglobulin M antibody
- Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
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 |
|---|---|---|
| Peginterferon Alfa-2Also: PegasysPeginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly. | Drug | Peginterferon Alfa-2a |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: From Baseline to end of treatment (up to 18 months)
6 secondary outcomes
Percentage of Participants with Histological Response According to Paired Biopsy
Time frame: At end of treatment (up to 18 months)
HIV RNA Viral Load in Copies per Milliliter (copies/mL)
Time frame: At end of treatment (up to 18 months)
Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL)
Time frame: At end of treatment (up to 18 months)
Percentage of Participants with Virological Response According to HCV RNA Viral Load
Time frame: At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall)
Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level
Time frame: At end of treatment (up to 18 months)
Percentage of Participants with Sustained Biochemical Response According to ALT Level
Time frame: At 24 weeks after end of treatment (up to 2 years overall)
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 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.
Clinical Trials study chair
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon Alfa-2 in people with HIV/HCV Coinfection, run by Hoffmann-La Roche at 10 sites in Belgium.
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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. 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?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
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 Adverse Events (AEs) (time frame: From Baseline to end of treatment (up to 18 months)). 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 7 Sep 2016.