A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

Completed · Phase 4 · Has a placebo group

Conditions studied: HIV Coinfection

In brief

To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

Key facts

Study ID

NCT01327547

Run by

ViiV Healthcare

People needed

138

Starts

2011-05-18

Expected to finish

2015-03-24

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV coinfected with HCV and/or HBV.
• Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
• Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.

You may not qualify if…

• Currently receiving maraviroc.
• Active opportunistic infections.
• ALT and/or AST >5x upper limit of normal.
• Direct bilirubin >1.5x upper limit of normal.
• Severe or decompensated liver disease.
• Liver disease unrelated to viral hepatitis infection.

Where it is running

• The Office of Dr. Franco Antonio Felizarta, M.D. — Bakersfield, California, United States
• AIDS Research Alliance — Los Angeles, California, United States
• Alameda Health System - Highland Hospital — Oakland, California, United States
• University of California Davis Research — Sacramento, California, United States
• University of California — Sacramento, California, United States
• University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG) — San Francisco, California, United States
• University of California, San Francisco - Mt. Zion Hospital — San Francisco, California, United States
• Community AIDS Resource Inc dba Care Resource — Miami, Florida, United States
• University of South Florida Health - HIV Clinical Research Unit — Tampa, Florida, United States
• Rowan Tree Medical, P.A. — Wilton Manors, Florida, United States
• Georgia Regents Medical Center — Augusta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Michael's Medical Center — Newark, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Mount Sinai Faculty Practice Associates — New York, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• I.D. Consultants, P.A. — Charlotte, North Carolina, United States
• Kaiser Permanente Sunnybrook Medical Office — Clackamas, Oregon, United States
• Kaiser Permanente Northwest — Portland, Oregon, United States
• Southwest Infectious Disease Clinical Research Inc. — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University Health Care Center Downtown — San Antonio, Texas, United States
• Fakultni nemocnice Brno — Brno, Czechia

Full record on ClinicalTrials.gov

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