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A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT (SUPPoRT)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Princy Kumar, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT00727597
First received: July 31, 2008
Last updated: June 28, 2013
Last verified: June 2013
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Infections
Interventions: Drug: Efavirenz 600mg
Drug: Boosted Lexiva

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Once Daily (QD) Regimen of Lexiva Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
QD Regimen of Sustiva QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Total Total of all reporting groups

Baseline Measures
   Once Daily (QD) Regimen of Lexiva   QD Regimen of Sustiva   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   50   101 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   50   50   100 
>=65 years   1   0   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.5  (2)   34  (2)   34  (2) 
Gender 
[Units: Participants]
     
Female   16   16   32 
Male   35   34   69 
Region of Enrollment 
[Units: Participants]
     
United States   51   50   101 


  Outcome Measures
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1.  Primary:   Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)   [ Time Frame: 96 weeks ]

2.  Primary:   Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events   [ Time Frame: 96 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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