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

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ClinicalTrials.gov Identifier: NCT00363142
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : September 24, 2009
Last Update Posted : November 5, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infection
Infection, Human Immunodeficiency Virus
Interventions: Drug: Half-boosted Fosamprenavir
Drug: Full Boosted Fosamprenavir

  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

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 
Overall Participants Analyzed 
[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

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

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 ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

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

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

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 ]
  Show Outcome Measure 7

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

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

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 ]
  Show Outcome Measure 10

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


  Serious Adverse Events

Time Frame No text entered.
Additional Description 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)

Serious Adverse Events
    FPV/r100   FPV/r200
Total, Serious Adverse Events     
# participants affected   7   1 
Cardiac disorders     
Cardiac failure congestive † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Gastrointestinal disorders     
Pancreatitis chronic † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Peptic ulcer † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
General disorders     
Chest pain † 1     
# participants affected / at risk   0/142 (0.00%)   1/67 (1.49%) 
Infections and infestations     
Appendicitis † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Cellulitis † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic neoplasm † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Nervous system disorders     
Central nervous system lesion † 2     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
Cerebrovascular accident † 1     
# participants affected / at risk   1/142 (0.70%)   0/67 (0.00%) 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA
2 Term from vocabulary, MeDRA




  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