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A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years

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ClinicalTrials.gov Identifier: NCT00040664
Recruitment Status : Completed
First Posted : July 10, 2002
Results First Posted : February 23, 2010
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: ritonavir
Drug: fosamprenavir
Enrollment 69
Recruitment Details Cohorts were recruited in parallel. All Age Cohorts were given the same treatment.
Pre-assignment Details The overall study population consisted of 69 participants presented as "Overall Fosamprenavir (FPV)/ritonavir (RTV)" in the Participant Flow section. Furthermore, the Overall FPV/RTV participants are stratified by age cohorts (Arms 2-4).
Arm/Group Title Overall Fosamprenavir (FPV)/Ritonavir(RTV) 2-5 Years FPV/RTV 6-11 Years FPV/RTV 12-18 Years FPV/RTV
Hide Arm/Group Description Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD) Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
Period Title: Overall Study
Started 69 [1] 17 17 35
Completed 16 4 4 8
Not Completed 53 13 13 27
Reason Not Completed
Adverse Event             12             3             2             7
Lack of Efficacy             9             2             3             4
Insufficient CD4 response             1             0             1             0
Lost to Follow-up             4             2             0             2
Protocol Violation             2             1             0             1
Withdrawal by Subject             7             0             3             4
Pregnancy             3             0             0             3
Medication adherence/compliance problems             8             2             1             5
Poor taste             2             0             2             0
Pharmacokinetic target not achieved             2             1             0             1
Change of formulation             2             2             0             0
Non-viability of oral suspension             1             0             1             0
[1]
All (69) enrolled on QD; 10 switched to twice daily. Participant flow not collected for this group.
Arm/Group Title FPV/RTV
Hide Arm/Group Description Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
Overall Number of Baseline Participants 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants
10.2  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
Female
39
  56.5%
Male
30
  43.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants
White/Caucasian 35
Black 24
East and South East Asian 1
American Hispanic 8
African Heritage 1
1.Primary Outcome
Title Number of Participants Who Discontinued Treatment Due to Adverse Events
Hide Description The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
Time Frame Baseline through end of study (at least Week 168)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants with documented evidence of having received at least one dose of study drug
Arm/Group Title FPV/RTV
Hide Arm/Group Description:
Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Participants
Any event 12
Nausea 3
Vomiting 3
Stomach discomfort 1
Hyperglycaemia 1
Hypertriglyceridaemia 1
Blood alkaline phosphatase increased 1
Hodgkin's disease 1
Haemoptysis 1
2.Primary Outcome
Title Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event
Hide Description The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).
Time Frame Baseline through end of study (at least Week 168)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants with documented evidence of having received at least one dose of study drug
Arm/Group Title FPV Tablet FPV Oral Suspension
Hide Arm/Group Description:
Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
Overall Number of Participants Analyzed 24 45
Measure Type: Number
Unit of Measure: Participants
All Grade 2-4 events 7 14
Vomiting 0 5
Diarrhea 2 1
Nausea 2 1
Blood alkaline phosphatase increased 1 1
Blood triglycerides increased 1 0
Abdominal pain 0 1
Benign salivary gland neoplasm 0 1
Blood cholesterol increased 1 0
Eosinophil count increased 0 1
Hemoptysis 0 1
Hyperglycemia 0 1
Hypertrichosis 0 1
Lipodystrophy acquired 1 0
Lipohypertrophy 0 1
Rash 0 1
Somnolence 1 0
Stomach discomfort 1 0
3.Primary Outcome
Title Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities
Hide Description The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.
Time Frame Baseline through end of study (at least Week 168)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants with documented evidence of having received at least one dose of study drug
Arm/Group Title FPV/RTV
Hide Arm/Group Description:
Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Participants
All parameters 6
Alanine aminotransferase 2
Aspartate aminotransferase 3
Cholesterol 0
Hyperglycemia 0
Hypoglycemia 0
Serum lipase 0
Triglycerides 1
Leucopenia 1
Neutropenia 12
Thrombocytopenia 2
Anemia 1
4.Primary Outcome
Title Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)
Hide Description Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 10 9 3 3
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours*micrograms/milliliter
47.3
(34.2 to 65.4)
47.6
(27.0 to 84.0)
75.5
(23.4 to 244)
71.8
(10.6 to 486)
5.Primary Outcome
Title Geometric Mean of Steady State Plasma APV Parameter: Cmax
Hide Description Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 10 9 3 3
Geometric Mean (95% Confidence Interval)
Unit of Measure: micrograms/milliliter
4.97
(3.76 to 6.58)
5.07
(2.50 to 10.3)
6.88
(4.31 to 11.0)
7.70
(2.70 to 21.9)
6.Primary Outcome
Title Median Steady State Plasma APV Tmax
Hide Description tmax: time after administration of the drug when maximum concentration is reached
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 10 9 3 3
Median (Full Range)
Unit of Measure: hours
1.04
(0.95 to 4.02)
1.12
(0.75 to 2.07)
1.08
(0.92 to 2.00)
3.78
(1.00 to 4.00)
7.Primary Outcome
Title Geometric Mean of Steady State Plasma APV Parameter: CL/F
Hide Description Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
Overall Number of Participants Analyzed 10 9 3 3
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliliters/minute/kilogram
10.5
(7.62 to 14.5)
10.6
(6.09 to 18.5)
6.57
(2.08 to 20.7)
4.95
(0.745 to 32.9)
8.Primary Outcome
Title Geometric Mean of Steady State Plasma APV Parameter: CL/F
Hide Description Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 3
Geometric Mean (95% Confidence Interval)
Unit of Measure: milliliters/minute
278
(41.2 to 1882)
9.Primary Outcome
Title Geometric Mean of Steady State Plasma APV Parameter: t1/2
Hide Description Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 10 9 3 3
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours
17.5
(11.1 to 27.7)
13.6
(9.02 to 20.4)
15.0
(7.93 to 28.2)
14.9
(4.78 to 46.4)
10.Primary Outcome
Title Least Squares Mean of Plasma APV Parameter: AUC0-tau
Hide Description A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
Overall Number of Participants Analyzed 10 9 3 3
Least Squares Mean (95% Confidence Interval)
Unit of Measure: hours*micrograms/milliliters
0.695
(0.578 to 0.835)
0.699
(0.577 to 0.848)
1.11
(0.800 to 1.54)
1.06
(0.761 to 1.47)
11.Primary Outcome
Title Least Squares Mean of Plasma APV Parameter: Cmax
Hide Description A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
Overall Number of Participants Analyzed 10 9 3 3
Least Squares Mean (95% Confidence Interval)
Unit of Measure: micrograms/milliliters
0.663
(0.555 to 0.791)
0.676
(0.560 to 0.814)
0.917
(0.667 to 1.26)
1.03
(0.747 to 1.41)
12.Primary Outcome
Title Least Squares Mean of Plasma APV Parameter: Ctau
Hide Description A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
Time Frame 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.
Arm/Group Title FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years
Hide Arm/Group Description:
FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
Overall Number of Participants Analyzed 10 9 3 3
Least Squares Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter
0.716
(0.548 to 0.936)
0.837
(0.663 to 1.06)
0.963
(0.696 to 1.33)
0.706
(0.568 to 0.878)
13.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.
Time Frame Weeks 12, 48, 96, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.
Arm/Group Title PI-Naive PI-Experienced
Hide Arm/Group Description:
Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
Participants treated with equal to or less than 3 PIs (any length of time)
Overall Number of Participants Analyzed 32 37
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 22 20
Week 48 16 16
Week 96 13 11
Week 168 11 7
14.Secondary Outcome
Title Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.
Time Frame Baseline and Weeks 12, 48, 96, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.
Arm/Group Title PI-Naive PI-Experienced
Hide Arm/Group Description:
Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
Participants treated with equal to or less than 3 PIs (any length of time)
Overall Number of Participants Analyzed 32 37
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
Week 12
-2.85
(-3.12 to -2.54)
-2.03
(-3.02 to -0.64)
Week 48
-2.65
(-3.31 to -1.44)
-1.65
(-2.76 to -1.02)
Week 96
-2.52
(-3.14 to -1.42)
-1.76
(-2.91 to -0.57)
Week 168
-2.88
(-3.49 to -2.15)
-2.39
(-3.13 to -0.94)
15.Secondary Outcome
Title Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits
Hide Description A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.
Time Frame Baseline and Weeks 12, 48, 96, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.
Arm/Group Title PI-Naive PI-Experienced
Hide Arm/Group Description:
Participants with equal to or less than 1 week of treatment with a PI
Participants treated with equal to or less than 3 PIs (any length of time)
Overall Number of Participants Analyzed 32 37
Median (Inter-Quartile Range)
Unit of Measure: Cells/mm3
Week 12
95
(10 to 150)
40
(-30 to 110)
Week 48
150
(75 to 280)
120
(0 to 240)
Week 96
160
(55 to 280)
40
(-180 to 180)
Week 168
180
(10 to 430)
0
(-220 to 200)
16.Secondary Outcome
Title Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline
Hide Description A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.
Time Frame Time of virologic failure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.
Arm/Group Title PI-Naive PI-Experienced
Hide Arm/Group Description:
Participants with equal to or less than 1 week of treatment with a PI
Participants treated with equal to or less than 3 PIs (any length of time)
Overall Number of Participants Analyzed 32 37
Measure Type: Number
Unit of Measure: Participants
2 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FPV/RTV
Hide Arm/Group Description Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
All-Cause Mortality
FPV/RTV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FPV/RTV
Affected / at Risk (%)
Total   19 
Blood and lymphatic system disorders   
Anemia  1  1/69 (1.45%) 
General disorders   
Pyrexia  1  2/69 (2.90%) 
Hepatobiliary disorders   
Hepatitis  1  1/69 (1.45%) 
Immune system disorders   
Drug hypersensitivity  1  3/69 (4.35%) 
Infections and infestations   
Measles  1  2/69 (2.90%) 
Appendicitis  1  1/69 (1.45%) 
Gastroenteritis  1  1/69 (1.45%) 
Pneumonia  1  1/69 (1.45%) 
Pneumonia bacterial  1  1/69 (1.45%) 
Injury, poisoning and procedural complications   
Eye penetration  1  1/69 (1.45%) 
Investigations   
Blood alkaline phosphatase increased  1  1/69 (1.45%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign salivary gland neoplasm  1  1/69 (1.45%) 
Nervous system disorders   
Headache  1  1/69 (1.45%) 
Psychiatric disorders   
Aggression  1  1/69 (1.45%) 
Anxiety  1  1/69 (1.45%) 
Bipolar disorder  1  1/69 (1.45%) 
Borderline personality disorder  1  1/69 (1.45%) 
Depression  1  1/69 (1.45%) 
Impulse control disorder  1  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis  1  1/69 (1.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FPV/RTV
Affected / at Risk (%)
Total   63 
Blood and lymphatic system disorders   
Lymphadenopathy  1  4/69 (5.80%) 
Eye disorders   
Conjunctivitis  1  4/69 (5.80%) 
Gastrointestinal disorders   
Vomiting  1  28/69 (40.58%) 
Diarrhoea  1  18/69 (26.09%) 
Nausea  1  16/69 (23.19%) 
Abdominal pain  1  7/69 (10.14%) 
Abdominal pain upper  1  4/69 (5.80%) 
Dental caries  1  4/69 (5.80%) 
General disorders   
Pyrexia  1  10/69 (14.49%) 
Infections and infestations   
Upper respiratory tract infection  1  17/69 (24.64%) 
Bronchitis  1  12/69 (17.39%) 
Nasopharyngitis  1  11/69 (15.94%) 
Otitis media  1  8/69 (11.59%) 
Influenza  1  6/69 (8.70%) 
Oral herpes  1  4/69 (5.80%) 
Pharyngitis  1  4/69 (5.80%) 
Pharyngitis streptococcal  1  4/69 (5.80%) 
Sinusitis  1  4/69 (5.80%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  4/69 (5.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  4/69 (5.80%) 
Nervous system disorders   
Headache  1  17/69 (24.64%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  16/69 (23.19%) 
Nasal congestion  1  6/69 (8.70%) 
Pharyngolaryngeal pain  1  5/69 (7.25%) 
Rhinorrhoea  1  5/69 (7.25%) 
Epistaxis  1  4/69 (5.80%) 
Rhinitis allergic  1  4/69 (5.80%) 
Skin and subcutaneous tissue disorders   
Rash  1  10/69 (14.49%) 
Acne  1  4/69 (5.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00040664     History of Changes
Other Study ID Numbers: APV 20003
First Submitted: July 5, 2002
First Posted: July 10, 2002
Results First Submitted: August 6, 2009
Results First Posted: February 23, 2010
Last Update Posted: March 3, 2017