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CCR5 Antagonist
Maraviroc for Immune Reconstitution Inflammatory Syndrome (CADIRIS Trial)
N/A
Waitlist Available
Led By Irini Sereti, M.D., MHS
Research Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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 baseline
Awards & highlights
CADIRIS Trial Summary
The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.
Eligible Conditions
- Immune Reconstitution Inflammatory Syndrome
- HIV/AIDS
- Human Immunodeficiency Virus Infection
CADIRIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to iris event
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to iris event
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to occurrence of an IRIS event
Secondary outcome measures
Baseline predictors of IRIS
Changes form baseline in CD4+ cells count
Frequency of AIDS defining events and AIDS related events in both arms of treatment
+16 moreSide effects data
From 2014 Phase 2 & 3 trial • 32 Patients • NCT011546736%
Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive HAART
Placebo Arm
CADIRIS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MaravirocExperimental Treatment1 Intervention
Maraviroc 600mg po BID
Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD) plus Maraviroc 600 mg BID
Group II: PlaceboPlacebo Group1 Intervention
Placebo po BID
Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD plus Placebo po BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
FDA approved
Find a Location
Who is running the clinical trial?
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranLead Sponsor
148 Previous Clinical Trials
27,948 Total Patients Enrolled
University of Witwatersrand, South AfricaOTHER
98 Previous Clinical Trials
9,944,060 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,821 Total Patients Enrolled
Frequently Asked Questions
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