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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Change from baseline in log HCV RNA values
Timepoint [1] 0 0
Baseline and week 48
Secondary outcome [2] 0 0
Proportiond of patients achieving undetectable HCV RNA levels
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
Proportion of patients achieving undetectable HCV RNA levels at Week 4
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [4] 0 0
Proportion of patients achieving undetectable HCV RNA levels at Week 12
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)
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
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
Proportion of patients achieving less than 25 IU/mL
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Proportion of patients with on-treatment virologic failure
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
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
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
Sex
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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
163
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01513941