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
Sponsor:
Information provided by (Responsible Party):
Carlos Brites, Fundação Bahiana de Infectologia
ClinicalTrials.gov Identifier:
NCT01837277
First received: April 18, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Severely Immunocompromised HIV Patients
Drug: Use of Raltegravir-based regimens
Drug: Efavirenz-based regimens
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment

Resource links provided by NLM:


Further study details as provided by Fundação Bahiana de Infectologia:

Primary Outcome Measures:
  • early mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viral load [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • CD4 count [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir Drug: Use of Raltegravir-based regimens
Active Comparator: Efavirenz Drug: Efavirenz-based regimens

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837277

Contacts
Contact: Estela Luz, RN, MSci 557132838123 eluz5@yahoo.com.br

Locations
Brazil
Fundação Bahiana de Infectologia/SEI Not yet recruiting
Salvador, Bahia, Brazil, 40010-160
Contact: Estela Luz, RN, MSci    32838123    eluz5@yahoo.com.br   
Principal Investigator: Carlos Brites, MD, PhD         
Sub-Investigator: Fabianna Bahia, MD, PhD         
Universidade Federal do Rio de Janeiro Not yet recruiting
Rio de Janeiro, RJ, Brazil
Contact: Monica Ponze, RN    5521222739073      
Principal Investigator: Mauro Schechter, MD, PhD         
Hospital de Clinicas de Porto Alegre Not yet recruiting
Porto Alegre, RS, Brazil
Contact: Priscila Pelaez, MD         
Principal Investigator: Eduardo Sprinz, MD, PhD         
Sponsors and Collaborators
Fundação Bahiana de Infectologia
  More Information

No publications provided

Responsible Party: Carlos Brites, Senior Investigator, Fundação Bahiana de Infectologia
ClinicalTrials.gov Identifier: NCT01837277     History of Changes
Other Study ID Numbers: SevereHIV
Study First Received: April 18, 2013
Last Updated: April 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014