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Impact of a Raltegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients

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. Identifier: NCT01837277
Recruitment Status : Unknown
Verified March 2015 by Carlos Brites, Fundação Bahiana de Infectologia.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2013
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):
Carlos Brites, Fundação Bahiana de Infectologia

Brief Summary:
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of RAL versus EFV in the early mortality rates for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.

Condition or disease Intervention/treatment Phase
Severely Immunocompromised HIV Patients Drug: Use of Raltegravir-based regimens Drug: Efavirenz-based regimens Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Raltegravir
Intervention: Patients will receive ART regimen based on investigational drug Raltegravir 400 mg BID + TDF 300 mg QD+ 3TC 150 mg BID
Drug: Use of Raltegravir-based regimens
Use of Raltegravir-based regimens: patients will receive a Raltegravir-based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)
Other Name: Isentress

Active Comparator: Efavirenz
Intervention: Patients will receive ART regimen based efavirenz (EFV 600 mg QD +TDF 300 mg QD+ 3TC 300 mg QD) for one year
Drug: Efavirenz-based regimens
Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
Other Name: Efavirenz

Primary Outcome Measures :
  1. early mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Viral load [ Time Frame: 24 months ]
  2. CD4 count [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
  • No previous use of any ARV drug (drug-naïve patients)
  • Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
  • Baseline CD4+ cells count equal or lower than 50 cells/mm3
  • Age equal or higher than 18 years
  • HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

  • Undetectable plasma viral load at screening
  • CD4 cells count>50 cells/mm3
  • Asymptomatic individuals

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 identifier (NCT number): NCT01837277

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Contact: Estela Luz, RN, MSci 557132838123

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Fundação Bahiana de Infectologia/SEI
Salvador, Bahia, Brazil, 40010-160
Contact: Estela Luz, RN, MSci    32838123   
Principal Investigator: Carlos Brites, MD, PhD         
Sub-Investigator: Fabianna Bahia, MD, PhD         
Universidade Federal do Rio de Janeiro
Rio de Janeiro, RJ, Brazil
Contact: Monica Ponze, RN    5521222739073      
Principal Investigator: Mauro Schechter, MD, PhD         
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil
Contact: Priscila Pelaez, MD         
Principal Investigator: Eduardo Sprinz, MD, PhD         
Sponsors and Collaborators
Fundação Bahiana de Infectologia

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Responsible Party: Carlos Brites, Senior Investigator, Fundação Bahiana de Infectologia Identifier: NCT01837277    
Other Study ID Numbers: SevereHIV
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers