Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Fundação Bahiana de Infectologia
Information provided by (Responsible Party):
Carlos Brites, Fundação Bahiana de Infectologia Identifier:
First received: April 18, 2013
Last updated: April 22, 2013
Last verified: April 2013

April 18, 2013
April 22, 2013
Not Provided
June 2014   (final data collection date for primary outcome measure)
early mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01837277 on Archive Site
  • Viral load [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • CD4 count [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Impact of a Raltegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS Patients
Not Provided

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.

Not Provided
Phase 2
Phase 3
Intervention Model: Parallel Assignment
Severely Immunocompromised HIV Patients
  • Drug: Use of Raltegravir-based regimens
  • Drug: Efavirenz-based regimens
  • Experimental: Raltegravir
    Intervention: Drug: Use of Raltegravir-based regimens
  • Active Comparator: Efavirenz
    Intervention: Drug: Efavirenz-based regimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not yet recruiting
Not Provided
Not Provided
June 2014   (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
18 Years to 65 Years
Contact: Estela Luz, RN, MSci 557132838123
Not Provided
Carlos Brites, Fundação Bahiana de Infectologia
Fundação Bahiana de Infectologia
Not Provided
Not Provided
Fundação Bahiana de Infectologia
April 2013

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