HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00450580
First received: March 21, 2007
Last updated: May 31, 2012
Last verified: April 2012
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infection, Human Immunodeficiency Virus I
HIV-1 Infection
Intervention: Drug: fosamprenavir/ritonavir

  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
No text entered.

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
FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily

Participant Flow:   Overall Study
    FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q     FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD  
STARTED     106     106  
COMPLETED     90     90  
NOT COMPLETED     16     16  
Adverse Event                 5                 7  
Lost to Follow-up                 4                 5  
Withdrawal by Subject                 2                 2  
Protocol Violation                 1                 1  
Protocol-defined virologic failure                 1                 0  
Could not comply with scheduled visits                 1                 0  
Patient went to Brazil                 1                 0  
Patient could not swallow Norvir                 1                 0  
Withdrawal due to pregnancy                 0                 1  



  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
FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
Total Total of all reporting groups

Baseline Measures
    FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q     FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD     Total  
Number of Participants  
[units: participants]
  106     106     212  
Age, Customized  
[units: years]
Mean ( Full Range )
  37  
  ( 18 to 70 )  
  38  
  ( 19 to 69 )  
  38  
  ( 18 to 70 )  
Gender  
[units: participants]
     
Female     27     29     56  
Male     79     77     156  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African heritage     23     22     45  
American Indian/Alaskan native     3     3     6  
Asian – South East Asian     2     2     4  
White – Arabic/North African     1     1     2  
White – White/Caucasian/European     75     78     153  
Mixed race     2     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks   [ Time Frame: Week 48 ]

3.  Secondary:   Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis   [ Time Frame: Week 48 ]

4.  Secondary:   Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis   [ Time Frame: Week 48 ]

5.  Secondary:   Change From Baseline in Non-HDL Cholesterol at Week 48   [ Time Frame: Week 48 ]

6.  Secondary:   Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes   [ Time Frame: Time to virologic failure; Week 4 up to Week 48 ]

7.  Secondary:   Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24   [ Time Frame: Weeks 4, 12, and 24 ]

8.  Secondary:   Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks   [ Time Frame: Up to 60 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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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


Publications:
Carosi G, Lazzarin A, Stellbrink H, et al. Efficacy and Safety of Fosamprenavir + Ritonavir (FPV/RTV) 700mg/100mg Twice Daily (BID) Versus FPV/RTV 1400mg/100mg Once Daily (QD) with ABC/3TC QD over 24 Weeks. Abstract H-1244, 48th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2008.

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00450580     History of Changes
Other Study ID Numbers: APV109141
Study First Received: March 21, 2007
Results First Received: July 24, 2009
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Ministry of Health and Consumption
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Italy: The Italian Medicines Agency