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

April 18, 2013
April 23, 2013
March 6, 2015
March 2015
March 2016   (Final data collection date for primary outcome measure)
early mortality [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01837277 on Archive Site
  • Viral load [ Time Frame: 24 months ]
  • CD4 count [ Time Frame: 24 months ]
Same as current
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Impact of a Raltegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
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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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Severely Immunocompromised HIV Patients
  • 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
  • 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
  • Experimental: Raltegravir
    Intervention: Patients will receive ART regimen based on investigational drug Raltegravir 400 mg BID + TDF 300 mg QD+ 3TC 150 mg BID
    Intervention: Drug: Use of Raltegravir-based regimens
  • 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
    Intervention: Drug: Efavirenz-based regimens
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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March 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Carlos Brites, Fundação Bahiana de Infectologia
Fundação Bahiana de Infectologia
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Fundação Bahiana de Infectologia
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP