A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | May 18, 2011 |
| End Date: | March 24, 2015 |
A Multicenter, Randomized, 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
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.
Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with
their current suppressive anti-HIV drug therapy.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
25
sites
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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New York Medical College The College was founded in 1860 by a group of New...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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1600 Holloway Avenue
San Francisco, California 94110
San Francisco, California 94110
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1701 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
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