A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

Recruiting at58 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Vertex Pharmaceuticals Incorporated

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

Research Team

Medical Monitor

Principal Investigator

Vertex Pharmaceuticals Incorporated

Eligibility Criteria

Inclusion Criteria

Population B: Peg-IFN/RBV prior null or partial responder

Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL)

Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse

Treatment Details

Interventions

• Pegylated Interferon Alfa-2a (Interferon)
• Ribavirin (Antiviral)
• Telaprevir (Protease Inhibitor)

Participant Groups

Group I: T/PR + HAART Regimen (RAL-Based) Experimental Treatment 4 Interventions

Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Group II: T/PR + HAART Regimen (EFV-Based) Experimental Treatment 4 Interventions

Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Group III: T/PR + HAART Regimen (ATV/r-Based) Experimental Treatment 4 Interventions

Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Pegylated Interferon Alfa-2a is already approved in Canada, China, Japan for the following indications:

Approved in Canada as Pegasys for:

• Chronic hepatitis C
• Chronic hepatitis B

Approved in China as Pegasys for:

• Chronic hepatitis C
• Chronic hepatitis B

Approved in Japan as Pegasys for:

• Chronic hepatitis C
• Chronic hepatitis B

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology