Infection, Human Immunodeficiency VirusPhase 3NCT00296504

A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

A Phase 3 study testing fosamprenavir (GW433908) and ritonavir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 24 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 years and older
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: fosamprenavir (GW433908) and ritonavir
How many people: 753 participants
Where: 24 sitesin 8 countries
Study dates: Nov 2001to Oct 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Who cannot join

Permanent discontinuation of GW433908 in a previous study due to intolerance.
An active CDC Class C Event.
Any condition which, in the opinion of the investigator, would preclude a subject from participation.

Trial locations and contacts

24 sites in 8 countries.

Country

City, postcode or hospital

24 sites in 8 countries

United States10 sites

GSK Investigational Site
Denver, Colorado, 80262
GSK Investigational Site
Fort Lauderdale, Florida, 33145
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Galveston, Texas, 77555-1188
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
San Francisco, California, 94115-1931
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Tampa, Florida, 33614

Other trials in United States

France6 sites

GSK Investigational Site
Le Kremlin-Bicêtre, 94275
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75970
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511
GSK Investigational Site
Villejuif, 94805

Other trials in France

Spain2 sites

GSK Investigational Site
Badajoz, 6080
GSK Investigational Site
Barcelona, 08036

Other trials in Spain

United Kingdom2 sites

GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, SE1 7EH

Other trials in United Kingdom

Brazil1 site

GSK Investigational Site
Campinas, São Paulo, 13083970

Other trials in Brazil

Chile1 site

GSK Investigational Site
Santiago, Región Metro de Santiago

Other trials in Chile

Italy1 site

GSK Investigational Site
Genoa, Liguria, 16128

Other trials in Italy

Portugal1 site

GSK Investigational Site
Coimbra, 3000-075

Other trials in Portugal

About this study

Official title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

Read the detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: fosamprenavir (GW433908), ritonavir
Keywords: antiretroviral therapy naive subjects, fosamprenavir, HIV-1, protease inhibitor, pro-drug, antiretroviral therapy, LEXIVA, AGENERASE, GW433908, amprenavir
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fosamprenavir (GW433908)Drug
ritonavirDrug
Also called fosamprenavir (GW433908)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Any Adverse Event (AE): Interim Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Measured: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants With Any Adverse Event (AE): Final Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Measured: Post January 2006; for up to 241 weeks
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Measured: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Measured: Weeks 120, 180, 204, 216, and 432
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Measured: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Measured: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Measured: Weeks 120, 180, 204, 216, and 432
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Measured: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Measured: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
Measured: Weeks 120, 180, 204, 216, and 432

Secondary outcomes (11)

Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Measured: Baseline and Weeks 48, 120, 180, and 216
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
Measured: Baseline and Weeks 12, 24, 48, 60, 96, and 132
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
Measured: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Measured: Baseline and Weeks 48, 120, 168, 180, 204, and 216
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Measured: Baseline and Weeks 24, 48, 96, 132, and 168
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Measured: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Measured: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Measured: Weeks 180, 240, 300, 360, 420, and 432
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
Measured: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
Measured: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed.
Measured: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Oct 2010

First posted27 Feb 2006 (estimated)
Study startNov 2001
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 753 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00296504
Sponsor's protocol ID: APV30005
Status last verified: Jun 2012
First submitted: 24 Feb 2006
Last updated: 19 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
ClinicalTrials.gov ID: NCT00296504
Acronym / sponsor ID: APV30005
Conditions: Infection, Human Immunodeficiency Virus
Keywords: antiretroviral therapy naive subjects, fosamprenavir, HIV-1, protease inhibitor, pro-drug, antiretroviral therapy, LEXIVA, AGENERASE
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 753 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Nov 2001
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 27 Feb 2006 (estimated)
Results: Posted 8 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Key exclusion criteria (3 listed)

Permanent discontinuation of GW433908 in a previous study due to intolerance.
An active CDC Class C Event.
Any condition which, in the opinion of the investigator, would preclude a subject from participation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fosamprenavir (GW433908)	Drug	–
ritonavirAlso: fosamprenavir (GW433908)	Drug	–

Primary outcome

Number of Participants With Any Adverse Event (AE): Interim Analysis
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Number of Participants With Any Adverse Event (AE): Final Analysis
Time frame: Post January 2006; for up to 241 weeks
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Time frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Time frame: Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Time frame: Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Time frame: Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.

11 secondary outcomes

Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Time frame: Baseline and Weeks 48, 120, 180, and 216
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Time frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Time frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Time frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Time frame: Baseline and Weeks 24, 48, 96, 132, and 168
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Time frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Time frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Time frame: Weeks 180, 240, 300, 360, 420, and 432
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)

Results and safety

Results posted to the registry on 8 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FPV Population (APV30001)	119	43
NFV Population (APV30001)	18	0
FPV Population (APV30002)	221	116
NFV Population (APV30002)	54	11
FPV/RTV Once Daily (QD) Population (APV30003)	73	36
FPV/RTV Twice Daily (BID) Population (APV30003)	78	41
Protease Inhibitor (PI)-Naïve Population (Other Studies)	104	30
PI-Experienced Population (Other Studies)	86	37
Final Analysis Population (APV30005)	0	0

Primary outcome: Number of Participants With Any Adverse Event (AE): Interim Analysis

Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264). Number. Unit: participants

Measure	FPV Population (APV30001) n = 119	NFV Population (APV30001) n = 18	FPV Population (APV30002) n = 221	NFV Population (APV30002) n = 54	FPV/RTV QD Population (APV30003) n = 73	FPV/RTV BID Population (APV30003) n = 78	PI-Naïve Population (Other Studies) n = 104	PI-Experienced Population (Other Studies) n = 86
Value	117	16	215	52	72	75	95	68

Population analysed: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.

Primary outcome: Number of Participants With Any Adverse Event (AE): Final Analysis

Time frame: Post January 2006; for up to 241 weeks. Number. Unit: participants

Measure	Final Analysis Population (APV30005) n = 111
Value	95

Population analysed: All participants who remained in the study after January 31, 2006.

Primary outcome: Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216

Time frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216. Median (Inter-Quartile Range). Unit: milligrams per deciliter (mg/dl)

Measure	FPV Population (APV30001) n = 92	NFV Population (APV30001) n = 14	FPV Population (APV30002) n = 159	NFV Population (APV30002) n = 38	FPV/RTV QD Population (APV30003) n = 61	FPV/RTV BID Population (APV30003) n = 65	PI-Naïve Population (Other Studies) n = 77	PI-Experienced Population (Other Studies) n = 59
Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59	10 (-34 to 42)	-41 (-63 to -20)	51 (14 to 118)	20 (-19 to 57)	9 (-25 to 44)	14 (-69 to 66)	5 (-27 to 58)	-54 (-96 to -12)
Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44	9 (-26 to 43)	-48 (-101 to 8)	47 (10 to 101)	15 (-22 to 48)	16 (-51 to 40)	34 (-21 to 118)	-5 (-35 to 42)	7 (-3 to 41)
Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40	15 (-24 to 59)	-33 (-77 to 0)	43 (2 to 121)	-4 (-24 to 69)	13 (-27 to 49)	22 (-39 to 96)	-4 (-50 to 50)	-73 (-283 to 2)
Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40	2 (-27 to 46)	-2 (-66 to 6)	47 (-0 to 101)	18 (-21 to 58)	14 (-63 to 65)	18 (-61 to 63)	6 (-48 to 32)	-129 (-343 to 75)
Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33	3 (-27 to 66)	-12 (-58 to 25)	27 (-19 to 86)	4 (-16 to 49)	29 (-55 to 59)	42 (-25 to 177)	5 (-32 to 27)	-167 (-238 to -10)
Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40	8 (-38 to 43)	-41 (-89 to 7)	37 (4 to 87)	18 (-16 to 81)	13 (-27 to 63)

Primary outcome: Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432

Time frame: Weeks 120, 180, 204, 216, and 432. Median (Inter-Quartile Range). Unit: milligrams per deciliter (mg/dl)

Measure	Final Analysis Population (APV30005) n = 106
Triglycerides; Week 120, n=14	237 (187 to 372)
Triglycerides; Week 180, n=14	248 (193 to 312)
Triglycerides; Week 204, n=106	137 (95 to 204)
Triglycerides; Week 216, n=102	120 (92 to 192)
Triglycerides; Week 432, n=40	132 (76 to 182)
Cholesterol; Week 120, n=14	202 (183 to 284)
Cholesterol; Week 180, n=14	206 (20 to 226)
Cholesterol; Week 204, n=106	201 (166 to 232)

Population analysed: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FPV Population (APV30001)	33 of 119 (27.7%)	115 of 119 (96.6%)	Not reported
NFV Population (APV30001)	1 of 18 (5.6%)	16 of 18 (88.9%)	Not reported
FPV Population (APV30002)	62 of 221 (28.1%)	209 of 221 (94.6%)	Not reported
NFV Population (APV30002)	7 of 54 (13%)	53 of 54 (98.1%)	Not reported
FPV/RTV QD Population (APV30003)	20 of 73 (27.4%)	68 of 73 (93.2%)	Not reported
FPV/RTV BID Population (APV30003)	14 of 78 (17.9%)	73 of 78 (93.6%)	Not reported
PI-Naïve Population (Other Studies)	7 of 104 (6.7%)	76 of 104 (73.1%)	Not reported
PI-Experienced Population (Other Studies)	13 of 86 (15.1%)	40 of 86 (46.5%)	Not reported
Final Analysis Population (APV30005)	15 of 111 (13.5%)	82 of 111 (73.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

ViiV Healthcare

24 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fosamprenavir (GW433908) and ritonavir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 24 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, France, Spain, United Kingdom, Brazil and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Event (AE): Interim Analysis (time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00296504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.