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

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. 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

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
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 

  Baseline Characteristics

  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

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

Responsible Party: Princy Kumar, MD, Georgetown University 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