A Study in Underrepresented Patient Population or Regimen Tolerability: 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients ≥18 years of age who were ART-naïve (≤14 days of treatment with any ART agent), HLA-B*5701-negative, and had a screening HIV-1 RNA >5000 copies/mL. Patients were required to be of minority race or ethnicity; white, non-Hispanic patients were not eligible for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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)

Participant Flow:   Overall Study
    Once Daily (QD) Regimen of Lexiva     QD Regimen of Sustiva  
STARTED     51     50  
COMPLETED     51     50  
NOT COMPLETED     0     0  



  Baseline Characteristics


  Outcome Measures
  Show All 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
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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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  More Information
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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


No publications provided by Georgetown University

Publications automatically indexed to this study:

Responsible Party: Princy Kumar, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00727597     History of Changes
Other Study ID Numbers: COL 110408
Study First Received: July 31, 2008
Results First Received: August 28, 2012
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration