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CCR5 Inhibitor
Maraviroc for Kidney Disease
Phase 2
Waitlist Available
Led By Peter Stock, MD, PhD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 time points in year 1 (four time points: weeks 13, 26, 39, 52)
Awards & highlights
Study Summary
This study is evaluating whether a drug called maraviroc may help prevent HIV from being transmitted to organ recipients.
Eligible Conditions
- Kidney Disease
- Human Immunodeficiency Virus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time points in year 1 (four time points: weeks 13, 26, 39, 52)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time points in year 1 (four time points: weeks 13, 26, 39, 52)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Incidence of Graft Loss, Toxicities ≥ Grade 3 Per the DAIDS Toxicity Table and/or Permanent Treatment Discontinuation
Mean Glomerular Filtration Rate by Iohexol Clearance at Week 52
Secondary outcome measures
AUC of CCR5 Blockade (Maraviroc)
Calcineurin Inhibitor (Tacrolimus) AUC for Participants on Maraviroc Versus Placebo
Calcineurin Inhibitor (Tacrolimus) Trough Levels for Participants on Maraviroc Versus Placebo
+23 moreSide effects data
From 2008 Phase 4 trial • 18 Patients • NCT006667056%
Folliculitis
6%
Constipation
6%
Peripheral neurophathy
6%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maraviroc
Maraviroc + Raltegravir
Raltegravir
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Maraviroc (MVC)Experimental Treatment1 Intervention
Participants will receive MVC at the time of admission for transplantation and prior to transplant. Participants will receive MVC throughout their participation in the study, which will be 1 to 3 years depending on when they enroll.
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
Participants will receive placebo at the time of admission for transplantation and prior to transplant. Participants will receive placebo throughout their participation in the study, which will be 1 to 3 years depending on when they enroll.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maraviroc
2014
Completed Phase 4
~1770
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,140 Total Patients Enrolled
Peter Stock, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
76 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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