Trial record 4 of 74 for:    Open Studies | "Antiretroviral Therapy, Highly Active" OR HAART

Early Antiviral Therapy for Critically Ill HIV Infected Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hospital Nossa Senhora da Conceicao
Sponsor:
Information provided by (Responsible Party):
Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
NCT01455688
First received: October 17, 2011
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.


Condition Intervention Phase
HIV Infection
Drug: early HAART
Drug: Late HAART
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Antiretroviral Therapy for Critically Ill HIV Infected Patients

Resource links provided by NLM:


Further study details as provided by Hospital Nossa Senhora da Conceicao:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    It is a estimative of length of hospital stay


Secondary Outcome Measures:
  • 6-month mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 344
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early antiviral therapy Drug: early HAART
Initiation of HAART within 5 days of ICU admission
Active Comparator: Conventional therapy Drug: Late HAART
Initiation of HAART after ICU discharge

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infection
  • CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age > 55 years, coinfection with HBV or HCV, neoplasia, viral load > 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness

Exclusion Criteria:

  • Regular use of HAART
  • Pregnant
  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: NCT01455688

Contacts
Contact: Marcio M Boniatti, PhD 33572221 marciobt@terra.com.br

Locations
Brazil
Hospital Nossa Senhora da Conceicao Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Marcio M Boniatti, PhD    33572221    marciobt@terra.com.br   
Principal Investigator: Marcio M Boniatti, PhD         
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao
  More Information

No publications provided

Responsible Party: Marcio Manozzo Boniatti, Principal investigator, Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier: NCT01455688     History of Changes
Other Study ID Numbers: ARV-0112
Study First Received: October 17, 2011
Last Updated: September 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Nossa Senhora da Conceicao:
critically ill patients
HIV infection
HAART
mortality

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Critical Illness
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014