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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
Sponsor:
Collaborator:
GlaxoSmithKline
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
Enrollment 101
Recruitment Details 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  
Arm/Group Title Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Hide Arm/Group Description Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Period Title: Overall Study
Started 51 50
Completed 51 50
Not Completed 0 0
Arm/Group Title Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva Total
Hide Arm/Group Description Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) Total of all reporting groups
Overall Number of Baseline Participants 51 50 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
  98.0%
50
 100.0%
100
  99.0%
>=65 years
1
   2.0%
0
   0.0%
1
   1.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 50 participants 101 participants
33.5  (2) 34  (2) 34  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
Female
16
  31.4%
16
  32.0%
32
  31.7%
Male
35
  68.6%
34
  68.0%
69
  68.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 50 participants 101 participants
51 50 101
1.Primary Outcome
Title Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Hide Arm/Group Description:
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Overall Number of Participants Analyzed 51 50
Measure Type: Number
Unit of Measure: participants
1 2
2.Primary Outcome
Title Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events
Hide Description [Not Specified]
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Hide Arm/Group Description:
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Overall Number of Participants Analyzed 51 50
Measure Type: Number
Unit of Measure: participants
2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Hide Arm/Group Description Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
All-Cause Mortality
Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/51 (3.92%)      2/50 (4.00%)    
Cardiac disorders     
Cardiac Arrest *  1/51 (1.96%)  1 0/50 (0.00%)  0
Endocrine disorders     
Acute Pancreatitis *  0/51 (0.00%)  0 1/50 (2.00%)  1
Immune system disorders     
Suspected Drug Hypersensitivity to ABC *  1/51 (1.96%)  1 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Once Daily (QD) Regimen of Lexiva QD Regimen of Sustiva
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/51 (17.65%)      15/50 (30.00%)    
General disorders     
cholesterol, total neutrophils, creatine kinase, and triglycerides *  9/51 (17.65%)  9 15/50 (30.00%)  15
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Princy Kumar
Organization: Georegtown University
Phone: 2024440086
EMail: kumarp@georgetown.edu
Layout table for additonal information
Responsible Party: Princy Kumar, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00727597    
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