Clinical trial NCT01513941: An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
Genotype 1 chronic hepatitis C
Treatment experienced with HCV-1/HIV-1 coinfection
Telaprevir
Pegylated-Interferon-alfa-2a
Ribavirin
HCV-1/HIV-1 coinfection
Hepatitis C
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Eligibility criteria: 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

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

Primary outcomes:
measure: Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Change from baseline in log HCV RNA values
timeFrame: Baseline and week 48
measure: Proportiond of patients achieving undetectable HCV RNA levels
timeFrame: Up to 48 weeks
measure: Proportion of patients achieving undetectable HCV RNA levels at Week 4
timeFrame: Up to 48 weeks
measure: Proportion of patients achieving undetectable HCV RNA levels at Week 12
timeFrame: Up to 48 weeks
measure: Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)
timeFrame: Up to 48 weeks
measure: Proportion of patients achieving undetectable HCV RNA at the actual end of treatment
timeFrame: Up to 48 weeks
measure: Proportion of patients achieving less than 25 IU/mL
timeFrame: Up to 48 weeks
measure: Proportion of patients with on-treatment virologic failure
timeFrame: Up to 48 weeks
measure: Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels
timeFrame: Up to 48 weeks
measure: Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Cairns
country: Australia
city: Darlinghurst
country: Australia
city: Melbourne
country: Australia
city: Campinas
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Santo André
country: Brazil
city: Sao Paulo
country: Brazil
city: Le Kremlin Bicetre
country: France
city: Marseille
country: France
city: Nice N/A
country: France
city: Paris Cedex 12
country: France
city: Bydgoszcz
country: Poland
city: Myslowice
country: Poland
city: Warszawa
country: Poland
city: Krasnodar
country: Russian Federation
city: Perm
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Alicante
country: Spain
city: Badalona
country: Spain
city: Cordoba
country: Spain
city: Elche
country: Spain
city: Madrid
country: Spain
city: San Sebastian
country: Spain
city: Sevilla N/A
country: Spain
city: Valencia
country: Spain
city: Stockholm
country: Sweden
city: Birmingham
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV, Belgium Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, Gonzalez-Garcia J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.