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
No text entered.

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
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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.
No text entered.

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  
Number of Participants  
[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 ]

Measure Type Primary
Measure Title Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)
Measure Description

Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:

  • To resolve a Grade 3 or 4 Adverse Event
  • The subject experienced a virologic failure (as defined in section 3.6.2)
  • The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue
  • The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)
Time Frame 96 weeks  
Safety Issue Yes  

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.
No text entered.

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)

Measured Values
    Once Daily (QD) Regimen of Lexiva     QD Regimen of Sustiva  
Number of Participants Analyzed  
[units: participants]
  51     50  
Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)  
[units: participants]
  1     2  

No statistical analysis provided for Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)



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

Measure Type Primary
Measure Title Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events
Measure Description No text entered.
Time Frame 96 weeks  
Safety Issue Yes  

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.
No text entered.

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)

Measured Values
    Once Daily (QD) Regimen of Lexiva     QD Regimen of Sustiva  
Number of Participants Analyzed  
[units: participants]
  51     50  
Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events  
[units: participants]
  2     3  

No statistical analysis provided for Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events




  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