Maraviroc (CCR5) Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients
NCT ID: NCT00988780
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
276 participants
INTERVENTIONAL
2009-12-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Maraviroc
Maraviroc 600mg po BID
Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD) plus Maraviroc 600 mg BID
maraviroc
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.
Placebo
Placebo po BID
Background antiretroviral regimen (Efavirenz 600mg QD + Tenofovir 300 mg /Emtricitabine 200 mg QD plus Placebo po BID
Placebo
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.
Interventions
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maraviroc
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* All women of reproductive potential (have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative serum or urine b-HCG pregnancy test performed within 7 days before study entry.
* Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable.
* All subjects must agree not to participate in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must agree to use a form of contraception as specified in the note below while receiving protocol-specified medication(s) and for one month after stopping the medication(s).
* Ability and willingness of subject or legal guardian/representative to give written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Witwatersrand, South Africa
OTHER
Case Western Reserve University
OTHER
The Wistar Institute
OTHER
University of Pennsylvania
OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Juan G. Sierra Madero
Infectious Diseases Specialist
Principal Investigators
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Ian Sanne, MBBCH, FCP
Role: PRINCIPAL_INVESTIGATOR
University of the Witwatersrand. Themba Lethu Clinic.
Michael M. Lederman, MD
Role: PRINCIPAL_INVESTIGATOR
Center for AIDS Research. Case Western Reserve University
Luis J Montaner, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
HIV-1 Immunopathogenesis Laboratory. The Wistar Institute
Livio Azzoni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HIV-1 Immunopathogenesis Laboratory. The Wistar Institute
Juan G Sierra Madero, MD
Role: PRINCIPAL_INVESTIGATOR
Insituto Nacional de Nutricion de Ciencias Medicas y Nutricion Salvador Zubiran
Susan Ellenberg, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine
Irini Sereti, M.D., MHS
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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NIH/NIAD
Bethesda, Maryland, United States
Center for AIDS Research. Case Western Reserve University
Cleveland, Ohio, United States
Center for Clinical Epidemiology and Biostatistics. University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
HIV-1 Immunopathogenesis Laboratory. The Wistar Institute
Philadelphia, Pennsylvania, United States
Hospital General de León
León, Guanajuato, Mexico
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
Hospital General de México
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, Mexico
Clinical HIV Research Unit. Themba Lethu Clinic. Helen Joseph Hospital
Johannesburg, Gauteng, South Africa
Countries
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References
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Araujo-Pereira M, Barreto-Duarte B, Arriaga MB, Musselwhite LW, Vinhaes CL, Belaunzaran-Zamudio PF, Rupert A, Montaner LJ, Lederman MM, Sereti I, Madero JGS, Andrade BB. Relationship Between Anemia and Systemic Inflammation in People Living With HIV and Tuberculosis: A Sub-Analysis of the CADIRIS Clinical Trial. Front Immunol. 2022 Jun 23;13:916216. doi: 10.3389/fimmu.2022.916216. eCollection 2022.
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.
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.
Other Identifiers
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The CADIRIS Study
Identifier Type: -
Identifier Source: org_study_id