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CCR5 Antagonist

Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients (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 up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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
  • Mycobacterium Avium Complex
  • Immune Reconstitution Inflammatory Syndrome
  • HIV/AIDS
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 2 & 3 trial • 32 Patients • NCT01154673
6%
Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive HAART
Placebo Arm

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
152 Previous Clinical Trials
28,810 Total Patients Enrolled
University of Witwatersrand, South AfricaOTHER
105 Previous Clinical Trials
10,090,458 Total Patients Enrolled
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
250,689 Total Patients Enrolled
The Wistar InstituteOTHER
8 Previous Clinical Trials
479 Total Patients Enrolled
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,257 Total Patients Enrolled
Irini Sereti, M.D., MHSPrincipal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
Juan G Sierra Madero, MDPrincipal InvestigatorInsituto Nacional de Nutricion de Ciencias Medicas y Nutricion Salvador Zubiran
Susan Ellenberg, Ph.D.Principal InvestigatorCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine
1 Previous Clinical Trials
453 Total Patients Enrolled
Ian Sanne, MBBCH, FCPPrincipal InvestigatorUniversity of the Witwatersrand. Themba Lethu Clinic.
Michael M. Lederman, MDPrincipal InvestigatorCenter for AIDS Research. Case Western Reserve University
2 Previous Clinical Trials
55 Total Patients Enrolled
~17 spots leftby Jan 2026
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