Phase 4 N=137 Randomized Double-blind Treatment

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

HIV Coinfection

Bottom Line

View on ClinicalTrials.gov: NCT01327547 ↗

Enrolled (actual)

137

Serious AEs

29.9%

Results posted

Nov 2014

Primary outcome: Primary: Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48 — 1.4; 1.5 Percentage of participants — p=0.4598

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Maraviroc (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ViiV Healthcare
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48	1.4; 1.5	0.4598
SECONDARY Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144	1.4; 3.0; 2.9; 4.5	—
SECONDARY Time to Development of Grade 3 and Grade 4 ALT Abnormalities	NA; NA	—
SECONDARY Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L	2.8; 4.4; 1.4; 0.0	—
SECONDARY Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L	NA; NA	—
SECONDARY Number of Participants With Hy's Law Abnormalities Through Week 144	0; 0	—
SECONDARY Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144	77.1; 79.1; 67.1; 70.1; 58.6; 67.2	—
SECONDARY Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144	3.1; 42.0; 7.8; 28.9; 5.1; 49.7	0.1174
SECONDARY Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144	-12.2; 43.0; 5.4; 47.4; 23.4; 50.7	0.0153 sig
SECONDARY Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.	0.4; 3.1; 0.0; -0.7; 0.6; -0.3	0.4476
SECONDARY Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144	-101.1; -20.4; -88.1; -23.1; -97.4; 9.8	0.9904
SECONDARY Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144	64.1; -165.0; -227.5; -296.5; 792.0; 1275.4	0.3786
SECONDARY Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144	-3.2; -3.2; -3.2; -3.4; -3.1; -3.3	0.8024
SECONDARY Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144	-2.6; -3.0; -3.3; -3.0; -3.4; -3.0	0.7778
SECONDARY Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144	0.2; 0.1; 0.4; 0.4; 0.4; 0.4	0.5201
SECONDARY Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144	-1.3; 0.4; -0.8; 0.4; -1.7; -0.3	0.1417
SECONDARY Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144	2.6; 1.5; 2.2; 1.5	—
SECONDARY Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144	3; 0; 2; 0; 0.0; 0.0	—
SECONDARY Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144	71.4; 70.1; 10.0; 5.0; 95.0; 95.0	—
SECONDARY Summary of Estimated Maraviroc PK Parameters	262; 166; 309; 496; 258; 915	—
SECONDARY Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48	0.892; 0.440; 0.766; 0.795; 0.087; 0.071	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01327547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.