Hepatitis CPhase 2NCT00983853
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
A Phase 2 study testing peginterferon alfa-2a, ribavirin (fixed dose) and ribavirin (weight-based dose) in people with Hepatitis C and HIV Infections, run by Vertex Pharmaceuticals Incorporated at 16 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, HIV Infections
- What is being tested?
- peginterferon alfa-2a, ribavirin (fixed dose) and ribavirin (weight-based dose)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Oct 2009to Mar 2012
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, genotype 1, hepatitis C with detectable HCV RNA
- HIV-1 infection for >6 months
- Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)
Who cannot join
- Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Previous treatment with interferon or ribavirin
- Evidence of hepatic decompensation in cirrhotic subjects
- Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
- Part A only: subjects who have been on a HAART regimen within 12 weeks before study start
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States11 sites
Study site
Baltimore, Maryland, 21287
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02114
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Dallas, Texas, 75204
Study site
Miami, Florida, 33125
Study site
New York, New York, 10029
Study site
Orlando, Florida, 32803
Study site
San Diego, California, 92093
Study site
San Francisco, California, 94110
About this study
Official title: A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).
- Conditions
- Hepatitis C, HIV Infections
- Being tested
- telaprevir or matching placebo, peginterferon alfa-2a, ribavirin (fixed dose), ribavirin (weight-based dose)
- Keywords
- VX-950, INCIVEK, INCIVO
- 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.
telaprevir or matching placeboDrug
Tablet, Oral, 750 mg, q8h, 12 weeks
telaprevir or matching placeboDrug
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
peginterferon alfa-2aBiological
Subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)Drug
Tablet, Oral, 800 mg, b.i.d., 48 weeks
ribavirin (weight-based dose)Drug
Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | The dose of ribavirin used (fixed versus weight-based) is region dependent Receives: Drug: telaprevir or matching placebo; Biological: peginterferon alfa-2a; Drug: ribavirin (fixed dose); Drug: ribavirin (weight-based dose) |
| Part B | Experimental | The dose of ribavirin used (fixed versus weight-based) is region dependent Receives: Drug: telaprevir or matching placebo; Biological: peginterferon alfa-2a; Drug: ribavirin (fixed dose); Drug: ribavirin (weight-based dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
Measured: 12 weeks after first dose of study drug
Secondary outcomes (5)
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
number of subjects with undetectable HCV RNA
Measured: 4 and 12 weeks after the first dose of study drug
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Measured: 12 weeks after last dose of study drug
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
Measured: through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
Measured: through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
Measured: through 12 weeks after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983853
- Sponsor's protocol ID
- VX08-950-110
- Status last verified
- Aug 2013
- First submitted
- 22 Sep 2009
- Last updated
- 10 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654.
PubMed 23685940
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
- ClinicalTrials.gov ID
- NCT00983853
- Acronym / sponsor ID
- VX08-950-110
- Conditions
- Hepatitis C, HIV Infections
- Keywords
- VX-950, INCIVEK, INCIVO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Posted 10 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: telaprevir or matching placebo, Biological: peginterferon alfa-2a, Drug: ribavirin (fixed dose), Drug: ribavirin (weight-based dose)The dose of ribavirin used (fixed versus weight-based) is region dependent |
| Part B | Experimental | Drug: telaprevir or matching placebo, Biological: peginterferon alfa-2a, Drug: ribavirin (fixed dose), Drug: ribavirin (weight-based dose)The dose of ribavirin used (fixed versus weight-based) is region dependent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic, genotype 1, hepatitis C with detectable HCV RNA
- HIV-1 infection for >6 months
- Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)
Key exclusion criteria (5 listed)
- Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Previous treatment with interferon or ribavirin
- Evidence of hepatic decompensation in cirrhotic subjects
- Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
- Part A only: subjects who have been on a HAART regimen within 12 weeks before study start
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 |
|---|---|---|
| telaprevir or matching placeboTablet, Oral, 750 mg, q8h, 12 weeks | Drug | Part A |
| telaprevir or matching placeboTablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks | Drug | Part B |
| peginterferon alfa-2aSubcutaneous injection, 180 μg, once weekly, 48 weeks | Biological | Part A, Part B |
| ribavirin (fixed dose)Tablet, Oral, 800 mg, b.i.d., 48 weeks | Drug | Part A, Part B |
| ribavirin (weight-based dose)Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks | Drug | Part A, Part B |
Primary outcome
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
Time frame: 12 weeks after first dose of study drug
5 secondary outcomes
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
Time frame: 4 and 12 weeks after the first dose of study drug
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Time frame: 12 weeks after last dose of study drug
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
Time frame: through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
Time frame: through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
Time frame: through 12 weeks after first dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23685940Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peginterferon alfa-2a, ribavirin (fixed dose) and ribavirin (weight-based dose) in people with Hepatitis C and HIV Infections, run by Vertex Pharmaceuticals Incorporated at 16 sites in 4 countries.
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 5 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 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Spain, 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?
Yes. Results are posted in the registry (first posted 10 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?
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 (time frame: 12 weeks after first dose of study drug). 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 NCT00983853, which also lists 1 linked publication.
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 10 Oct 2013.