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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988780
First Posted: October 2, 2009
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Witwatersrand, South Africa
Case Western Reserve University
The Wistar Institute
University of Pennsylvania
Information provided by (Responsible Party):
Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  Purpose
The purpose of this study is to determine if Maraviroc administration can decrease IRIS incidence in HIV infected patients initiating ARV therapy.

Condition Intervention
Immune Reconstitution Inflammatory Syndrome HIV HIV Infections Drug: maraviroc Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: CCR5 Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Time to occurrence of an IRIS event [ Time Frame: The initial 24 week period of observation ]

Secondary Outcome Measures:
  • Time to occurrence of a severe IRIS event [ Time Frame: The initial 24 week period of observation ]
  • Occurrence of either an IRIS event or death [ Time Frame: By 24 and 48 weeks ]
  • Proportion of subjects who develops an IRIS case [ Time Frame: By week 24 ]
  • Proportion of subjects who develop a severe IRIS case [ Time Frame: Week 24 ]
  • Proportion of subjects who develop a confirmed, non dermatologic IRIS case [ Time Frame: Week 24 ]
  • Proportion of subjects who develop an unmasking or paradoxical IRIS event [ Time Frame: Week 24 ]
  • Frequency of cardiovascular, cerebrovascular, non AIDS related neoplasia, cirrhosis, renal failure and death in both treatment arms [ Time Frame: During the study (from entry to week 60) ]
  • Frequency of AIDS defining events and AIDS related events in both arms of treatment [ Time Frame: From basline to study end ]
  • General survival [ Time Frame: At week 24 and 48 ]
  • Survival without IRIS [ Time Frame: At weeks 24 and 48 ]
  • Proportion of patients with VL<50 copies/mL [ Time Frame: At weeks 8, 24 and 48 ]
  • Changes form baseline in CD4+ cells count [ Time Frame: From baseline to weeks 12, 24 and 48 ]
  • Safety and tolerability of the treatment regimens [ Time Frame: Along the study ]
  • Incidence of HIV drug resistance [ Time Frame: Baseline to week 60 ]
  • Prevalence of CCR5 tropism [ Time Frame: Baseline ]
  • Prevalence of CCR5 HIV tropism [ Time Frame: At virological failure occurrence ]
  • Baseline predictors of IRIS [ Time Frame: Baseline ]
  • Genetic polymorphisms associated with the occurrence of IRIS [ Time Frame: Baseline ]
  • To evaluate the rol of biomarkers (CRP) in predicting or identifying IRIS and the effect of Maraviroc on this marker [ Time Frame: Baseline to IRIS event ]

Estimated Enrollment: 276
Study Start Date: December 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc

Maraviroc 600mg po BID

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

Drug: 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.

Other Names:
  • Selzentry
  • Stocrin
  • Truvada
Placebo Comparator: Placebo

Placebo po BID

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

Drug: 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 Names:
  • Stocrin
  • Truvada

Detailed Description:
This is a randomized, double blind, placebo-controlled, multicenter study testing the utility of a CCR5 antagonist (Maraviroc) as an adjuvant to a standard HAART regimen to decrease the incidence of Immune Reconstitution Inflammatory Syndrome (IRIS) in HIV-infected patients naïve to antiretroviral treatment. The study duration will be 60 weeks, 276 subjects (138 per arm) will be recruited. The population included will be HIV-infected patients starting antiretroviral (ARV) therapy at the participating centers in Mexico and South Africa with a CD4 T cell count <100 cells/ul. Subjects will be randomized to receive either Maraviroc (study drug) or placebo in addition to background ARV therapy. The background antiretroviral regimen for all subjects will be: Efavirenz 600mg QD + Tenofovir 300 mg / Emtricitabine 200 mg QD; subjects will be randomized to one of the following arms: Arm A: background ARV + maraviroc 600mg po BID; Arm B: background ARV + placebo po BID. Patients will be followed for 48 weeks. The primary endpoint will be the occurrence of a defined IRIS event by week 24 of follow up. The success of the ARV therapy will also be evaluated by virologic and immunologic response at 24 and 48 weeks. Three immunology sub-studies are planned: 1) Sub-study A will be conformed by a subgroup of 40 subjects (20 from Mexico and 20 from South Africa), additional blood sampling will be performed to evaluate expression of immune activation markers; movement of central memory T cells into cell cycle and frequencies of expandable pathogen-reactive CD4+ and CD8+ T cells in circulation; 2) Sub-study B will be conformed by another subgroup of 60 subjects (all from South Africa), additional blood sampling will be performed to evaluate monocyte and CD4 T cell gene expression as related to activation-induced apoptosis and cytokine secretion.; 3) Sub-study C will evaluate the incidence of thromboembolic disease in the study patients along with baseline evaluation of possible bio-markers of pro-coagulant state.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988780


Locations
United States, Maryland
NIH/NIAD
Bethesda, Maryland, United States, 20892
United States, Ohio
Center for AIDS Research. Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Center for Clinical Epidemiology and Biostatistics. University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
HIV-1 Immunopathogenesis Laboratory. The Wistar Institute
Philadelphia, Pennsylvania, United States, 19104
Mexico
Hospital General de León
Leon, Guanajuato, Mexico, 37230
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Hospital General de México
Mexico City, Mexico, 06726
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí, Mexico, 78240
South Africa
Clinical HIV Research Unit. Themba Lethu Clinic. Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
University of Witwatersrand, South Africa
Case Western Reserve University
The Wistar Institute
University of Pennsylvania
Investigators
Principal Investigator: 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 NIH/NIAID
  More Information

Publications:
Jensen-Fangel S, Pedersen L, Pedersen C, Larsen CS, Tauris P, Møller A, Sørensen HT, Obel N. Low mortality in HIV-infected patients starting highly active antiretroviral therapy: a comparison with the general population. AIDS. 2004 Jan 2;18(1):89-97.
Corey DM, Kim HW, Salazar R, Illescas R, Villena J, Gutierrez L, Sanchez J, Tabet SR. Brief report: effectiveness of combination antiretroviral therapy on survival and opportunistic infections in a developing world setting: an observational cohort study. J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):451-5.
Lederman MM. Immune restoration and CD4+ T-cell function with antiretroviral therapies. AIDS. 2001 Feb;15 Suppl 2:S11-5. Review.
Lawn SD, Myer L, Bekker LG, Wood R. CD4 cell count recovery among HIV-infected patients with very advanced immunodeficiency commencing antiretroviral treatment in sub-Saharan Africa. BMC Infect Dis. 2006 Mar 21;6:59.
Battegay M, Nüesch R, Hirschel B, Kaufmann GR. Immunological recovery and antiretroviral therapy in HIV-1 infection. Lancet Infect Dis. 2006 May;6(5):280-7. Review.
Murdoch DM, Venter WD, Van Rie A, Feldman C. Immune reconstitution inflammatory syndrome (IRIS): review of common infectious manifestations and treatment options. AIDS Res Ther. 2007 May 8;4:9.
Autran B, Carcelain G, Li TS, Blanc C, Mathez D, Tubiana R, Katlama C, Debré P, Leibowitch J. Positive effects of combined antiretroviral therapy on CD4+ T cell homeostasis and function in advanced HIV disease. Science. 1997 Jul 4;277(5322):112-6.
Shelburne SA, Visnegarwala F, Darcourt J, Graviss EA, Giordano TP, White AC Jr, Hamill RJ. Incidence and risk factors for immune reconstitution inflammatory syndrome during highly active antiretroviral therapy. AIDS. 2005 Mar 4;19(4):399-406.
Lederman MM, Penn-Nicholson A, Cho M, Mosier D. Biology of CCR5 and its role in HIV infection and treatment. JAMA. 2006 Aug 16;296(7):815-26. Review.
Westby M, van der Ryst E. CCR5 antagonists: host-targeted antivirals for the treatment of HIV infection. Antivir Chem Chemother. 2005;16(6):339-54. Review.
Knobel H, Alonso J, Casado JL, Collazos J, González J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13.
French MA, Lenzo N, John M, Mallal SA, McKinnon EJ, James IR, Price P, Flexman JP, Tay-Kearney ML. Immune restoration disease after the treatment of immunodeficient HIV-infected patients with highly active antiretroviral therapy. HIV Med. 2000 Mar;1(2):107-15.
Jevtović DJ, Salemović D, Ranin J, Pesić I, Zerjav S, Djurković-Djaković O. The prevalence and risk of immune restoration disease in HIV-infected patients treated with highly active antiretroviral therapy. HIV Med. 2005 Mar;6(2):140-3.
French MA, Price P, Stone SF. Immune restoration disease after antiretroviral therapy. AIDS. 2004 Aug 20;18(12):1615-27. Review.
Singh N, Perfect JR. Immune reconstitution syndrome associated with opportunistic mycoses. Lancet Infect Dis. 2007 Jun;7(6):395-401. Review.
Bonnet MM, Pinoges LL, Varaine FF, Oberhauser BB, O'Brien DD, Kebede YY, Hewison CC, Zachariah RR, Ferradini LL. Tuberculosis after HAART initiation in HIV-positive patients from five countries with a high tuberculosis burden. AIDS. 2006 Jun 12;20(9):1275-9.
Rodríguez-Rosado R, Soriano V, Dona C, González-Lahoz J. Opportunistic infections shortly after beginning highly active antiretroviral therapy. Antivir Ther. 1998;3(4):229-31.
Lortholary O, Fontanet A, Mémain N, Martin A, Sitbon K, Dromer F; French Cryptococcosis Study Group. Incidence and risk factors of immune reconstitution inflammatory syndrome complicating HIV-associated cryptococcosis in France. AIDS. 2005 Jul 1;19(10):1043-9.
Michelet C, Arvieux C, François C, Besnier JM, Rogez JP, Breux JP, Souala F, Allavena C, Raffi F, Garre M, Cartier F. Opportunistic infections occurring during highly active antiretroviral treatment. AIDS. 1998 Oct 1;12(14):1815-22.
Park WB, Choe PG, Jo JH, Kim SH, Bang JH, Kim HB, Kim NJ, Oh MD, Choe KW. Tuberculosis manifested by immune reconstitution inflammatory syndrome during HAART. AIDS. 2007 Apr 23;21(7):875-7.
Domingo P, Torres OH, Ris J, Vazquez G. Herpes zoster as an immune reconstitution disease after initiation of combination antiretroviral therapy in patients with human immunodeficiency virus type-1 infection. Am J Med. 2001 Jun 1;110(8):605-9.
Manosuthi W, Kiertiburanakul S, Phoorisri T, Sungkanuparph S. Immune reconstitution inflammatory syndrome of tuberculosis among HIV-infected patients receiving antituberculous and antiretroviral therapy. J Infect. 2006 Dec;53(6):357-63. Epub 2006 Feb 17.
Madec Y, Laureillard D, Pinoges L, Fernandez M, Prak N, Ngeth C, Moeung S, Song S, Balkan S, Ferradini L, Quillet C, Fontanet A. Response to highly active antiretroviral therapy among severely immuno-compromised HIV-infected patients in Cambodia. AIDS. 2007 Jan 30;21(3):351-9.
Braitstein P, Brinkhof MW, Dabis F, Schechter M, Boulle A, Miotti P, Wood R, Laurent C, Sprinz E, Seyler C, Bangsberg DR, Balestre E, Sterne JA, May M, Egger M; Antiretroviral Therapy in Lower Income Countries (ART-LINC) Collaboration; ART Cohort Collaboration (ART-CC) groups. Mortality of HIV-1-infected patients in the first year of antiretroviral therapy: comparison between low-income and high-income countries. Lancet. 2006 Mar 11;367(9513):817-24. Erratum in: Lancet. 2006 Jun 10;367(9526):1902.
Zachariah R, Fitzgerald M, Massaquoi M, Pasulani O, Arnould L, Makombe S, Harries AD. Risk factors for high early mortality in patients on antiretroviral treatment in a rural district of Malawi. AIDS. 2006 Nov 28;20(18):2355-60.
Sabin CA, Smith CJ, Gumley H, Murphy G, Lampe FC, Phillips AN, Prinz B, Youle M, Johnson MA. Late presenters in the era of highly active antiretroviral therapy: uptake of and responses to antiretroviral therapy. AIDS. 2004 Nov 5;18(16):2145-51.
Manabe YC, Campbell JD, Sydnor E, Moore RD. Immune reconstitution inflammatory syndrome: risk factors and treatment implications. J Acquir Immune Defic Syndr. 2007 Dec 1;46(4):456-62.
Lawn SD, Myer L, Bekker LG, Wood R. Tuberculosis-associated immune reconstitution disease: incidence, risk factors and impact in an antiretroviral treatment service in South Africa. AIDS. 2007 Jan 30;21(3):335-41.
Delves PJ, Roitt IM. The immune system. First of two parts. N Engl J Med. 2000 Jul 6;343(1):37-49. Review.
Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60.
Egger M, Hirschel B, Francioli P, Sudre P, Wirz M, Flepp M, Rickenbach M, Malinverni R, Vernazza P, Battegay M. Impact of new antiretroviral combination therapies in HIV infected patients in Switzerland: prospective multicentre study. Swiss HIV Cohort Study. BMJ. 1997 Nov 8;315(7117):1194-9.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
Storey JD, Tibshirani R. Statistical significance for genomewide studies. Proc Natl Acad Sci U S A. 2003 Aug 5;100(16):9440-5. Epub 2003 Jul 25.
Lederman MM, Margolis L. The lymph node in HIV pathogenesis. Semin Immunol. 2008 Jun;20(3):187-95. doi: 10.1016/j.smim.2008.06.001. Epub 2008 Jul 14. Review.
Sieg SF, Bazdar DA, Lederman MM. S-phase entry leads to cell death in circulating T cells from HIV-infected persons. J Leukoc Biol. 2008 Jun;83(6):1382-7. doi: 10.1189/jlb.0907643. Epub 2008 Mar 27.
Sieg SF, Rodriguez B, Asaad R, Jiang W, Bazdar DA, Lederman MM. Peripheral S-phase T cells in HIV disease have a central memory phenotype and rarely have evidence of recent T cell receptor engagement. J Infect Dis. 2005 Jul 1;192(1):62-70. Epub 2005 May 26.
Brenchley JM, Price DA, Schacker TW, Asher TE, Silvestri G, Rao S, Kazzaz Z, Bornstein E, Lambotte O, Altmann D, Blazar BR, Rodriguez B, Teixeira-Johnson L, Landay A, Martin JN, Hecht FM, Picker LJ, Lederman MM, Deeks SG, Douek DC. Microbial translocation is a cause of systemic immune activation in chronic HIV infection. Nat Med. 2006 Dec;12(12):1365-71. Epub 2006 Nov 19.
Jiang W, Lederman MM, Hunt P, Sieg SF, Haley K, Rodriguez B, Landay A, Martin J, Sinclair E, Asher AI, Deeks SG, Douek DC, Brenchley JM. Plasma levels of bacterial DNA correlate with immune activation and the magnitude of immune restoration in persons with antiretroviral-treated HIV infection. J Infect Dis. 2009 Apr 15;199(8):1177-85. doi: 10.1086/597476. Erratum in: J Infect Dis. 2009 Jul 1;200(1):160.
Funderburg N, Luciano AA, Jiang W, Rodriguez B, Sieg SF, Lederman MM. Toll-like receptor ligands induce human T cell activation and death, a model for HIV pathogenesis. PLoS One. 2008 Apr 2;3(4):e1915. doi: 10.1371/journal.pone.0001915.
Pandrea I, Apetrei C, Gordon S, Barbercheck J, Dufour J, Bohm R, Sumpter B, Roques P, Marx PA, Hirsch VM, Kaur A, Lackner AA, Veazey RS, Silvestri G. Paucity of CD4+CCR5+ T cells is a typical feature of natural SIV hosts. Blood. 2007 Feb 1;109(3):1069-76. Epub 2006 Sep 26.
Bourgarit A, Carcelain G, Martinez V, Lascoux C, Delcey V, Gicquel B, Vicaut E, Lagrange PH, Sereni D, Autran B. Explosion of tuberculin-specific Th1-responses induces immune restoration syndrome in tuberculosis and HIV co-infected patients. AIDS. 2006 Jan 9;20(2):F1-7.
Salkowitz JR, Sieg SF, Harding CV, Lederman MM. In vitro human memory CD8 T cell expansion in response to cytomegalovirus requires CD4+ T cell help. J Infect Dis. 2004 Mar 15;189(6):971-83. Epub 2004 Mar 1.
Ratnam I, Chiu C, Kandala NB, Easterbrook PJ. Incidence and risk factors for immune reconstitution inflammatory syndrome in an ethnically diverse HIV type 1-infected cohort. Clin Infect Dis. 2006 Feb 1;42(3):418-27. Epub 2005 Dec 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan G. Sierra Madero, Infectious Diseases Specialist, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00988780     History of Changes
Other Study ID Numbers: The CADIRIS Study
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Immune reconstitution inflammatory syndrome
CCR5 antagonist
Maraviroc
HIV
treatment naive

Additional relevant MeSH terms:
Syndrome
HIV Infections
Immune Reconstitution Inflammatory Syndrome
Disease
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Efavirenz
Maraviroc
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers


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