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Antiretroviral Therapy

Combination Antiretroviral Therapy for Primary Biliary Cholangitis

Phase 2
Waitlist Available
Led By Andrew Mason, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation baseline, 3 months, 6 months and end of rct; then 3 months, 6 monthly to end of open label therapy
Awards & highlights

Study Summary

This trial is testing a new combination therapy for primary biliary cholangitis (PBC) patients who have not responded to Ursodeoxycholic Acid (UDCA). The trial will compare the new therapy to a placebo, and all patients will be offered the new therapy after the trial is completed.

Who is the study for?
This trial is for adults over 18 with Primary Biliary Cholangitis (PBC) who haven't responded to Ursodeoxycholic Acid. They must have a stable dose of UDCA or be intolerant to it, and show certain levels of liver enzymes or bilirubin. Excluded are those with advanced liver disease, other serious conditions, recent non-standard therapies, heavy alcohol use in the past year, pregnancy, or inadequate kidney function.Check my eligibility
What is being tested?
The study tests Tenofovir Disoproxil and Raltegravir against a placebo in PBC patients unresponsive to UDCA. It's a double-blind RCT where participants don't know if they're getting real treatment or placebo for 12 months; then there's an open label phase. A parallel observational study involves liver transplant recipients on these drugs plus Emtricitabine.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea, possible allergic reactions, fatigue, headaches and muscle pain from Raltegravir; while Tenofovir might cause kidney problems and bone loss. FTC could lead to skin discoloration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation baseline, 3 months, 6 months and end of rct; then 3 months, 6 monthly to end of open label therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluation baseline, 3 months, 6 months and end of rct; then 3 months, 6 monthly to end of open label therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in alkaline phosphatase levels
Secondary outcome measures
Achievement of the composite biochemistry endpoint
Human Betaretrovirus load in peripheral blood
Interferon gamma release to Human Betaretrovirus peptide stimulation
+4 more

Side effects data

From 2017 Phase 4 trial • 107 Patients • NCT01989910
4%
Anemia
2%
Hypertriglycemia
2%
CK Elevation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raltegravir
Efavirenz

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & RaltegravirExperimental Treatment2 Interventions
one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets
Group II: PlaceboPlacebo Group1 Intervention
Identical tablets resembling one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Raltegravir
2011
Completed Phase 4
~2060
Emtricitabine (FTC)/Tenofovir Disoproxil (TDF)
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,741 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,534 Total Patients Enrolled
Andrew Mason, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
2,513 Total Patients Enrolled

Media Library

Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03954327 — Phase 2
Primary Biliary Cirrhosis Research Study Groups: Placebo, Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & Raltegravir
Primary Biliary Cirrhosis Clinical Trial 2023: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) Highlights & Side Effects. Trial Name: NCT03954327 — Phase 2
Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03954327 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide details on other research endeavors related to Raltegravir?

"Currently, there are 94 studies involving Raltegravir. Of those, 29 have advanced to Phase 3 of the clinical trial process. Boylston, Massachusetts is home for the majority of these trials; however, a total of 1605 sites around the world offer this medication as part of their research pursuits."

Answered by AI

What medicinal applications commonly employ Raltegravir?

"Raltegravir is utilised to address hiv-1 and also offers therapeutic benefits in cases of HIV infection, transmission, and human immunodeficiency virus type 1 (hiv-1) contagion."

Answered by AI

Are there any participating establishments administering this clinical investigation within the state?

"This study is inviting individuals to participate at Vancouver General Hospital, University of Brittish Columbia in Vancouver (BC), Royal University Hospital in Saskatoon (SK) and the University of Alberta in Edmonton (AB). Moreover, other 6 sites are also participating."

Answered by AI

What is the current status of Raltegravir with regard to governmental authorization?

"The safety of Raltegravir is assessed to be a 2, as this phase 2 clinical trial has some evidence showing that it's safe but not yet any information regarding its efficacy."

Answered by AI

What is the current participant quota for this research trial?

"Affirmative. The information on clinicaltrials.gov confirms that this trial is actively inviting candidates to participate; the project was introduced at the start of March 2021 and just recently updated in mid-March 2022. 60 participants will be accepted from 6 different medical centres."

Answered by AI

Are there any open positions for clinical trial participants?

"Clinicaltrials.gov confirms that this medical trial, initially posted on March 1st 2021 is currently seeking participants. The study was last modified on March 15th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combination Antiretroviral Therapy (cART) for PBC
2021. "Combination Antiretroviral Therapy (cART) for PBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03954327.
~9 spots leftby Apr 2025
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