Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients

NCT00988780 | Unknown DMC

• 1 other identifier: The CADIRIS Study
• Study Type: interventional
• Target: 276
• Locations: 3 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.

Conditions

Immune Reconstitution Inflammatory Syndrome; HIV; HIV Infections

Keywords

Immune reconstitution inflammatory syndrome; CCR5 antagonist; Maraviroc; HIV; treatment naive

Outcome Measures

Primary Outcomes (1)

• Time to occurrence of an IRIS event

  The initial 24 week period of observation

Secondary Outcomes (19)

• Time to occurrence of a severe IRIS event

  The initial 24 week period of observation

• Occurrence of either an IRIS event or death

  By 24 and 48 weeks

• Proportion of subjects who develops an IRIS case

  By week 24

• Proportion of subjects who develop a severe IRIS case

  Week 24

• Proportion of subjects who develop a confirmed, non dermatologic IRIS case

  Week 24

Study Arms (2)

Maraviroc

EXPERIMENTAL

Maraviroc 600mg po BID Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD) plus Maraviroc 600 mg BID

Drug: maraviroc

Placebo

PLACEBO COMPARATOR

Placebo po BID Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD plus Placebo po BID

Drug: Placebo

Interventions

maraviroc DRUG

Maraviroc 600mg po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.

Also known as: Selzentry, Stocrin, Truvada

Maraviroc

Placebo DRUG

Placebo tablets po BID every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Efavirenz 600 mg qd every day from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops. Tenofovir/Emtricitabine 300/200 mg qd from the entry visit until week 48 or until IRIS event or unacceptable toxicity develops.

Also known as: Stocrin, Truvada

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection, as documented by any licensed rapid test kit and confirmed by Western blot or ELISA test kit at any time prior to study enrollment.
• Plasma HIV-1 RNA is acceptable as an alternative confirmatory test.
• Men and women age \> 18 years.
• Have not received any antiretroviral treatment before entering the study.
• Patients who received Single dose nevirapine or any duration of AZT for PMTC will not be considered ARV naïve.
• CD4+ cell count of \</=100 cells/mm3 obtained within 90 days prior to study entry.
• HIV RNA level \> 1,000 copies/mL obtained within 90 days prior to study entry.
• Patients with an opportunistic or HIV-related infection may be included according to the clinical judgment of the main investigator in each center when the patient is ready and able to start ARV therapy.
• Laboratory values obtained within 30 days prior to study entry:
• Absolute neutrophil count (ANC) \> 500/mm3.
• Hemoglobin \> 8.0 g/dL.
• Platelet count \> 50,000/mm3.
• AST (SGOT), ALT (SGPT), and alkaline phosphatase minor of 5 times ULN.
• Total bilirubin minor of 2.5 times ULN.
• Creatinine clearance minor of 50\* mL/min as estimated by the Cockcroft-Gault equation or Creatinine Clearance \> 50ml/min as calculated by a formal creatinine clearance measurement

You may not qualify if:

• Pregnancy and breast-feeding.
• Active neoplasia or previous history of neoplasia. (Except localized non visceral Kaposi´s Sarcoma; localized squamous or basal cell carcinoma of the skin, or intraepithelial cervical neoplasia grade III or less).
• Use of the following drugs within 180 days prior to study entry: systemic cancer chemotherapy, systemic investigational agents, and immunomodulators (growth factors, immune globulin, interleukins, interferons).
• Use of systemic corticosteroids in the last 2 weeks prior to randomization.
• Decompensated liver disease (defined as stage C of Child-Pugh classification) at the beginning of the study.
• An altered mental status that in the opinion of the investigator, will compromise the adherence to the protocol.
• Allergy/sensitivity to study drug(s) or their formulations that cannot be substituted by another agent as described in section 5.1
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Serious illness that renders a subject unable to take the antiretroviral study regimen.
• Serious medical illness that in the opinion of the investigator compromises the adherence and/or follow up of the protocol.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• University of Witwatersrand, South Africa: collaborator
• Case Western Reserve University: collaborator
• The Wistar Institute: collaborator
• University of Pennsylvania: collaborator

Study Sites (10)

NIH/NIAD

Bethesda, Maryland, 20892, United States

Location

Center for AIDS Research. Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Center for Clinical Epidemiology and Biostatistics. University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

HIV-1 Immunopathogenesis Laboratory. The Wistar Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital General de León

León, Guanajuato, 37230, Mexico

Location

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Hospital General de México

Mexico City, Mexico City, 06726, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Clinical HIV Research Unit. Themba Lethu Clinic. Helen Joseph Hospital

Johannesburg, Gauteng, 2092, South Africa

Location

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• Sierra-Madero JG, Ellenberg SS, Rassool MS, Tierney A, Belaunzaran-Zamudio PF, Lopez-Martinez A, Pineirua-Menendez A, Montaner LJ, Azzoni L, Benitez CR, Sereti I, Andrade-Villanueva J, Mosqueda-Gomez JL, Rodriguez B, Sanne I, Lederman MM; CADIRIS study team. Effect of the CCR5 antagonist maraviroc on the occurrence of immune reconstitution inflammatory syndrome in HIV (CADIRIS): a double-blind, randomised, placebo-controlled trial. Lancet HIV. 2014 Nov;1(2):e60-7. doi: 10.1016/S2352-3018(14)70027-X. Epub 2014 Oct 21.

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• Sierra-Madero JG, Ellenberg S, Rassool MS, Tierney A, Belaunzaran-Zamudio PF, Lopez-Martinez A, Pineirua-Menendez A, Montaner LJ, Azzoni L, Benitez CR, Sereti I, Andrade-Villanueva J, Mosqueda-Gomez JL, Rodriguez B, Sanne I, Lederman MM; CADIRIS study team. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study. Lancet HIV. 2014 Nov 1;1(2):e60-e67. doi: 10.1016/S2352-3018(14)70027-X.

  PMID: 26366430 DERIVED

MeSH Terms

Conditions

Immune Reconstitution Inflammatory Syndrome; HIV Infections

Interventions

Maraviroc; efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ian Sanne, MBBCH, FCP

  University of the Witwatersrand. Themba Lethu Clinic.

  PRINCIPAL INVESTIGATOR

• Michael M. Lederman, MD

  Center for AIDS Research. Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Luis J Montaner, M.Sc.

  HIV-1 Immunopathogenesis Laboratory. The Wistar Institute

  PRINCIPAL INVESTIGATOR

• Livio Azzoni, MD, PhD

  HIV-1 Immunopathogenesis Laboratory. The Wistar Institute

  PRINCIPAL INVESTIGATOR

• Juan G Sierra Madero, MD

  Insituto Nacional de Nutricion de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Susan Ellenberg, Ph.D.

  Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine

  PRINCIPAL INVESTIGATOR

• Irini Sereti, M.D., MHS

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases Specialist

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

ME (5); ZA (1); US (4)