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

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ClinicalTrials.gov Identifier: NCT00727597
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
Princy Kumar, MD, Georgetown University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Infections
Interventions: Drug: Efavirenz 600mg
Drug: Boosted Lexiva

  Participant Flow

  Baseline Characteristics

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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   50   50   100 
>=65 years   1   0   1 
[Units: Years]
Mean (Standard Deviation)
 33.5  (2)   34  (2)   34  (2) 
[Units: Participants]
Female   16   16   32 
Male   35   34   69 
Region of Enrollment 
[Units: Participants]
United States   51   50   101 

  Outcome Measures

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

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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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Princy Kumar
Organization: Georegtown University
phone: 2024440086
e-mail: kumarp@georgetown.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Princy Kumar, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00727597     History of Changes
Other Study ID Numbers: COL 110408
First Submitted: July 31, 2008
First Posted: August 4, 2008
Results First Submitted: August 28, 2012
Results First Posted: July 2, 2013
Last Update Posted: July 2, 2013