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Trial record 6 of 31 for:    " October 12, 2011":" November 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Early Antiviral Therapy for Critically Ill HIV Infected 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.
ClinicalTrials.gov Identifier: NCT01455688
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao

Tracking Information
First Submitted Date  ICMJE October 17, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date April 12, 2018
Actual Study Start Date  ICMJE January 1, 2012
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
Hospital mortality [ Time Frame: 4 weeks ]
It is a estimative of length of hospital stay
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01455688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
6-month mortality [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Antiviral Therapy for Critically Ill HIV Infected Patients
Official Title  ICMJE Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Drug: early HAART
    Initiation of HAART within 5 days of ICU admission
  • Drug: Late HAART
    Initiation of HAART after ICU discharge
Study Arms
  • Experimental: Early antiviral therapy
    Intervention: Drug: early HAART
  • Active Comparator: Conventional therapy
    Intervention: Drug: Late HAART
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
115
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2011)
344
Actual Study Completion Date June 30, 2016
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01455688
Other Study ID Numbers  ICMJE ARV-0112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao
Study Sponsor  ICMJE Hospital Nossa Senhora da Conceicao
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Nossa Senhora da Conceicao
Verification Date April 2018

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