A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363142
First received: August 11, 2006
Last updated: October 21, 2010
Last verified: October 2010
Results First Received: June 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infection
Infection, Human Immunodeficiency Virus
Interventions: Drug: Half-boosted Fosamprenavir
Drug: Full Boosted Fosamprenavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified prior to randomization according to baseline regimen (700 milligrams [mg]/100 mg twice a day [BID] or 1400 mg/200 mg once a day [QD]) and previous regimen (no other prior protease inhibitor [PI], non-boosted PI, or boosted PI). Results are reported for the 209 participants (out of 211 enrolled) receiving study drug.

Reporting Groups
  Description
FPV/r100 Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
FPV/r200 FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)

Participant Flow:   Overall Study
    FPV/r100     FPV/r200  
STARTED     140     69  
COMPLETED     133     66  
NOT COMPLETED     7     3  
Adverse Event                 2                 0  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 1                 0  
Non-compliance                 1                 1  
Withdrawal by Subject                 3                 1  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
FPV/r100 Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
FPV/r200 FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
Total Total of all reporting groups

Baseline Measures
    FPV/r100     FPV/r200     Total  
Number of Participants  
[units: participants]
  140     69     209  
Age  
[units: years]
Mean ± Standard Deviation
  44.9  ± 10.52     44.3  ± 8.9     44.7  ± 10.00  
Gender  
[units: participants]
     
Female     33     9     42  
Male     107     60     167  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African heritage     42     20     62  
American Indian/Alaskan native     1     0     1  
Asian - South East Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     1     1  
White - Arabic/North African     0     2     2  
White - White/Caucasian/European     95     44     139  
Mixed race     1     0     1  
Other     1     0     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     31     11     42  
Not Hispanic or Latino     109     58     167  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis   [ Time Frame: Week 24 ]

4.  Secondary:   Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24   [ Time Frame: Baseline through Week 24 ]

7.  Secondary:   Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24   [ Time Frame: Baseline through Week 24 ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24   [ Time Frame: Baseline and Week 24 ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24
Measure Description A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.
Time Frame Baseline and Week 24  
Safety Issue No  

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.
Safety Population

Reporting Groups
  Description
FPV/r100 Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
FPV/r200 FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)

Measured Values
    FPV/r100     FPV/r200  
Number of Participants Analyzed  
[units: participants]
  123     60  
Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24  
[units: Percent┬áchange]
Median ( Full Range )
   
Total cholesterol     -0.5  
  ( -41.8 to 31.3 )  
  0.7  
  ( -35.4 to 91 )  
HDL     -2.1  
  ( -34.8 to 47.4 )  
  0  
  ( -34.1 to 31.7 )  
Triglycerides     -13.5  
  ( -87.7 to 169.2 )  
  -0.6  
  ( -52.2 to 191.1 )  

No statistical analysis provided for Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24



9.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline   [ Time Frame: Baseline through Week 24 ]

11.  Secondary:   Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24   [ Time Frame: Weeks 12 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00363142     History of Changes
Other Study ID Numbers: LEX106430
Study First Received: August 11, 2006
Results First Received: June 11, 2009
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration