A4001098 - Maraviroc Study in HIV-1 coinfected pts

• Research type

  Research Study

• Full title

  A Multi-Centre, Randomised, Blinded, Placebo-Controlled Study to Evaluate the Safety of Maraviroc in Combination with Other Antiretroviral Agents in HIV-1 Infected Subjects Co-Infected With Hepatitis C and / or Hepatitis B Virus

• IRAS ID

  76998

• Sponsor organisation

  Viiv Healthcare UK Ltd

• Eudract number

  2010-021994-35

• ISRCTN Number

  not known

• Research summary

  Study A4001098 is being conducted to evaluate the safety of maraviroc compared to placebo (a placebo looks like the study drug but does not contain any active drug) in subjects who are infected with HIV-1 and are also infected with Hepatitis C virus (HCV) and/or Hepatitis B virus (HBV). A second reason for this study is to see if maraviroc has any effect in slowing or stopping any ongoing liver damage.The study is open to both men and women at least 18 years of age that are currently being treated with medications to treat the HIV virus. The study will be conducted at dedicated research centers and hospitals. The study will last for approximately 152 weeks during which the following tests will be performed: physical exams, blood draws for laboratory tests and a fibroscan (select sites only).A liver biopsy sub-study is also planned; 24 subjects (12 from each treatment arm) will be recruited into the sub-study to explore the antifibrotic activity of maraviroc.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0785

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Favourable Opinion