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NCT01327547 · ClinicalTrials.gov registry record · Phase 4
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
A Phase 4 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 138
- Enrollment target
NCT01327547: Completed Phase 4 study, sponsored by ViiV Healthcare.
NCT01327547 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 138 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327547, a Phase 4 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 138 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as \>5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or \>3.5x baseline for participants whose baseline ALT \>ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
Interventions
- DRUG Placebo
- DRUG Maraviroc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2011-05-18 |
| Est. Completion | 2015-03-24 |
| Phase | Phase 4 |
What the finished NCT01327547 record still lists
NCT01327547 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01327547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327547 about?
NCT01327547 is a clinical study titled "A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B". 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.
What is the current status of trial NCT01327547?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 138 participants. The study started on 2011-05-18. Estimated completion is 2015-03-24.
What interventions are being tested in trial NCT01327547?
The interventions under investigation include: Placebo (DRUG), Maraviroc (DRUG).
Who is sponsoring clinical trial NCT01327547?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327547's enrollment target sits among peer trials
138 593rd of 2000 higher than 1,407 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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