The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01513941




Registration number
NCT01513941
Ethics application status
Date submitted
16/01/2012
Date registered
20/01/2012
Date last updated
5/05/2016

Titles & IDs
Public title
An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)
Scientific title
Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection
Secondary ID [1] 0 0
VX-950HPC3008
Secondary ID [2] 0 0
CR100778
Universal Trial Number (UTN)
Trial acronym
INSIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Telaprevir
Treatment: Drugs - Ribavirin
Treatment: Drugs - Pegylated-Interferon-alfa-2a

Experimental: Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV) - All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 µg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.


Treatment: Drugs: Telaprevir
Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.

Treatment: Drugs: Ribavirin
Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.

Treatment: Drugs: Pegylated-Interferon-alfa-2a
Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels - Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Change from baseline in log HCV RNA values - Change from baseline in log HCV RNA values at each time point during treatment.
Timepoint [1] 0 0
Baseline and week 48
Secondary outcome [2] 0 0
Proportiond of patients achieving undetectable HCV RNA levels - Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
Proportion of patients achieving undetectable HCV RNA levels at Week 4 - The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [4] 0 0
Proportion of patients achieving undetectable HCV RNA levels at Week 12 - Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR) - Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
Proportion of patients achieving undetectable HCV RNA at the actual end of treatment - Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
Proportion of patients achieving less than 25 IU/mL - Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Proportion of patients with on-treatment virologic failure - Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
Timepoint [8] 0 0
Up to 48 weeks
Secondary outcome [9] 0 0
Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels - Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.
Timepoint [9] 0 0
Up to 48 weeks
Secondary outcome [10] 0 0
Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels - Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
Timepoint [10] 0 0
Up to 48 weeks

Eligibility
Key inclusion criteria
- Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or
histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1
with HCV RNA level greater than 1,000 IU/mL

- Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening
visit

- CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3
within 6 months of screening visit

- HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the
screening visit

- No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit

- Currently taking one of the permitted anti-HIV regimens for greater than or equal to12
weeks
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Anticipated need to switch anti-HIV regimen from screening through the Telaprevir
treatment period

- Infection or co-infection with HCV other than genotype 1

- Contraindication to the administration of Peg-IFN-alfa or RBV

- Hepatitis B virus (HBV) co-infection

- Acute or active condition of HIV-associated opportunistic infection within 6 months of
screening

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Cairns
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Campinas
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio De Janeiro
Country [3] 0 0
Brazil
State/province [3] 0 0
Santo André
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
France
State/province [5] 0 0
Le Kremlin Bicetre
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Nice N/A
Country [8] 0 0
France
State/province [8] 0 0
Paris Cedex 12
Country [9] 0 0
Poland
State/province [9] 0 0
Bydgoszcz
Country [10] 0 0
Poland
State/province [10] 0 0
Myslowice
Country [11] 0 0
Poland
State/province [11] 0 0
Warszawa
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Krasnodar
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Perm
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Saint-Petersburg
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Smolensk
Country [16] 0 0
Russian Federation
State/province [16] 0 0
St Petersburg
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Voronezh
Country [18] 0 0
Spain
State/province [18] 0 0
Alicante
Country [19] 0 0
Spain
State/province [19] 0 0
Badalona
Country [20] 0 0
Spain
State/province [20] 0 0
Cordoba
Country [21] 0 0
Spain
State/province [21] 0 0
Elche
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
San Sebastian
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla N/A
Country [25] 0 0
Spain
State/province [25] 0 0
Valencia
Country [26] 0 0
Sweden
State/province [26] 0 0
Stockholm
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Birmingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Glasgow
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag International NV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given
with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of
hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human
immunodeficiency virus (HIV-1).
Trial website
https://clinicaltrials.gov/show/NCT01513941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag International NV, Belgium Clinical Trial
Address 0 0
Janssen-Cilag International NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications