HIV InfectionPhase 2NCT00040664
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
A Phase 2 study testing ritonavir and fosamprenavir in people with HIV Infection, run by ViiV Healthcare at 42 sites in 7 countries.
Trial summary
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- ritonavir and fosamprenavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 42 sitesin 7 countries
- Study dates
- Jul 2002to Oct 2008
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or females 2 to 18 years of age
- A female is eligible to enter and participate in this study if she is of:
- a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial); or,
- b. child-bearing potential with a negative serum pregnancy test at screen, a negative urine pregnancy test on Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician). Note: hormonal contraceptives are not considered a sufficient form of contraceptive for this study.
- Complete abstinence from intercourse from 2 weeks prior to administration of study drugs, throughout the study and for 2 weeks after discontinuation of all study medications. Should a female subject of childbearing potential decide to become sexually active during the course of the study, she must be counselled and be willing to use one of the methods listed below:
- Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
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- Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion)
- Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year. All subjects participating in this study should be counselled on the practice of safe/safer sex.
- Parent or legal guardian (and subject whenever possible) has the ability to understand and provide written informed consent for the subject to participate in the trial. Verbal witnessed assent must be obtained from the subject whenever possible.
- Screening plasma HIV-1 RNA > or =400copies/mL.
- Subject's who, in the investigator's opinion, and following resistance testing where appropriate, are able to construct an active NRTI backbone regimen consisting of 2 NRTIs.
- Subjects must meet one of the following criteria:
- ART-naïve subjects are defined as having had < 4 weeks (28 days) therapy with an NRTI, no previous therapy with an NNRTI and < 1 week therapy with an HIV PI.
- ART-experienced subjects are defined as having had greater than 4 weeks (28 days) therapy with any NRTI(s) and any length of therapy with any NNRTI(s) and/or a PI. PI-experienced subjects will be eligible if they have previously been treated with < three PIs, excluding AGENERASE. Prior therapy with a RTV boosted PI regimen will be considered as only 1 prior PI as long as the RTV dose was below that recommended for use of RTV as an antiretroviral agent. This specific criterion is not applicable to subjects in screening and/or enrolling after approval of Amendment No. 4. - For subjects screening and/or enrolling after the approval of Amendment No.4, PI naive subjects are defined as ART experienced subjects having less than one week of therapy with a PI and no prior experience with AGENERASE. Prior treatment with NNRTIs and NRTIs is permitted (however, subjects will NOT be permitted to receive concurrent NNRTI therapy while participating in this study)
Who cannot join
- Prior history of having received amprenavir.
- Use of non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days of study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
- Have had an AIDS defining illness (acute CDC Category C event) within 28 days of screening.
- Pregnant or lactating.
- Non-nucleoside reverse transcriptase inhibitor therapy within 14 days prior to study drug administration or anticipated need for concurrent NNRTI therapy during the study period.
- Subjects who, in the investigator's opinion, are not able to comply with the requirements of the study.
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- An acute CDC Category C event (per 1993/1994 classification) and/or serious bacterial infection(s) within 28 days prior to study drug administration.
- Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
- Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia,diabetes, cardiac dysfunction and hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
- Current grade 2 or higher serum lipase within 28 days prior to study drug administration and/or history of clinically relevant pancreatitis within the previous 6 months. - Grade 3 or 4 transaminase levels (ALT and/or AST) within 28 days prior to study drug administration and/or clinically relevant hepatitis within the previous 6 months.
- Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period.
- Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration.
- Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study:
- Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepin, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, simvastatin, terfenadine, triazolam, zolpidem (these drugs have been excluded for safety reasons).
- Carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, St Johns Wort (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations) - Systemic chemotherapeutic agents
- Treatment with other investigational drugs/therapies (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor) within 28 days prior to study drug administration
- History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g., documented hypersensitivity to a nucleoside analogue).
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United States17 sites
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7220
GSK Investigational Site
Chicago, Illinois, 60614
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
Stony Brook, New York, 11794-8111
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
The Bronx, New York, 10457
Spain9 sites
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08950
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Valencia, 46009
Italy8 sites
GSK Investigational Site
Florence, Tuscany, 55100
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Modena, Emilia-Romagna, 41150
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Rome, Lazio, 00165
Portugal3 sites
GSK Investigational Site
Amadora, 2700
GSK Investigational Site
Lisbon, 1150
GSK Investigational Site
Lisbon, 1649-035
Canada2 sites
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Toronto, Ontario, M5G 1X8
Romania2 sites
GSK Investigational Site
Bucharest, 021105
GSK Investigational Site
Bucharest, 030303
About this study
Official title: A 48 Week, Phase II, Open-Label Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and GW433908/Ritonavir BID When Administered to HIV-1 Infected, Antiretroviral Naive and Experienced, Pediatric Subjects 2-18 Years Old
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.
Read the detailed description
A 48 Week, Phase II, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and GW433908/Ritonavir BID when Administered to HIV-1 Infected, Antiretroviral Naive and Experience Pediatric Subjects 2 to 18 Years Old
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
- HIV Infection
- Being tested
- ritonavir, fosamprenavir
- Keywords
- pediatrics, HIV, protease inhibitors, ritonavir, fosamprenavir, LEXIVA, AGENERASE, amprenavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ritonavirDrug
Also called fosamprenavir
ritonavir oral capsules or oral solution
fosamprenavirDrug
fosamprenavir oral suspension or tablet
| Study group | Role | What they receive |
|---|---|---|
| 2 to 5 years (FPV/RTV) | Experimental | Two to five 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) Receives: Drug: ritonavir; Drug: fosamprenavir |
| 6 to 11 years (FPV/RTV) | Experimental | Six to twelve 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) Receives: Drug: ritonavir; Drug: fosamprenavir |
| 12 to 18 years (FPV/RTV) | Experimental | Twelve to Eighteen 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) Receives: Drug: ritonavir; Drug: fosamprenavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Discontinued Treatment Due to Adverse Events
The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
Measured: Baseline through end of study (at least Week 168)
Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event
The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).
Measured: Baseline through end of study (at least Week 168)
Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities
The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.
Measured: Baseline through end of study (at least Week 168)
Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Geometric Mean of Steady State Plasma APV Parameter: Cmax
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Median Steady State Plasma APV Tmax
tmax: time after administration of the drug when maximum concentration is reached
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Geometric Mean of Steady State Plasma APV Parameter: CL/F
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Geometric Mean of Steady State Plasma APV Parameter: t1/2
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Least Squares Mean of Plasma APV Parameter: AUC0-tau
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Least Squares Mean of Plasma APV Parameter: Cmax
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
Least Squares Mean of Plasma APV Parameter: Ctau
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.
Measured: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
Secondary outcomes (4)
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)
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.
Measured: Weeks 12, 48, 96, and 168
Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits
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.
Measured: Baseline and Weeks 12, 48, 96, and 168
Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits
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.
Measured: Baseline and Weeks 12, 48, 96, and 168
Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline
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.
Measured: Time of virologic failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2002 (estimated)
- Study startJul 2002
- Primary completionOct 2008
- Study completionOct 2008
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 HIV InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040664
- Sponsor's protocol ID
- APV 20003
- Status last verified
- Jan 2017
- First submitted
- 5 Jul 2002
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48 Week, Phase II, Open-Label Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and GW433908/Ritonavir BID When Administered to HIV-1 Infected, Antiretroviral Naive and Experienced, Pediatric Subjects 2-18 Years Old
- ClinicalTrials.gov ID
- NCT00040664
- Acronym / sponsor ID
- APV 20003
- Conditions
- HIV Infection
- Keywords
- pediatrics, HIV, protease inhibitors, ritonavir, fosamprenavir, LEXIVA, AGENERASE, amprenavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Jul 2002 (estimated)
- Results
- Posted 23 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.
Detailed description
A 48 Week, Phase II, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and GW433908/Ritonavir BID when Administered to HIV-1 Infected, Antiretroviral Naive and Experience Pediatric Subjects 2 to 18 Years Old
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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 to 5 years (FPV/RTV) | Experimental | Drug: ritonavir, Drug: fosamprenavirTwo to five 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 to 11 years (FPV/RTV) | Experimental | Drug: ritonavir, Drug: fosamprenavirSix to twelve 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 to 18 years (FPV/RTV) | Experimental | Drug: ritonavir, Drug: fosamprenavirTwelve to Eighteen 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) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Male or females 2 to 18 years of age
- A female is eligible to enter and participate in this study if she is of:
- a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial); or,
- b. child-bearing potential with a negative serum pregnancy test at screen, a negative urine pregnancy test on Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician). Note: hormonal contraceptives are not considered a sufficient form of contraceptive for this study.
- Complete abstinence from intercourse from 2 weeks prior to administration of study drugs, throughout the study and for 2 weeks after discontinuation of all study medications. Should a female subject of childbearing potential decide to become sexually active during the course of the study, she must be counselled and be willing to use one of the methods listed below:
Key exclusion criteria (17 listed)
- Prior history of having received amprenavir.
- Use of non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days of study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
- Have had an AIDS defining illness (acute CDC Category C event) within 28 days of screening.
- Pregnant or lactating.
- Non-nucleoside reverse transcriptase inhibitor therapy within 14 days prior to study drug administration or anticipated need for concurrent NNRTI therapy during the study period.
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 |
|---|---|---|
| ritonavirAlso: fosamprenavirritonavir oral capsules or oral solution | Drug | 12 to 18 years (FPV/RTV), 2 to 5 years (FPV/RTV), 6 to 11 years (FPV/RTV) |
| fosamprenavirfosamprenavir oral suspension or tablet | Drug | 12 to 18 years (FPV/RTV), 2 to 5 years (FPV/RTV), 6 to 11 years (FPV/RTV) |
Primary outcome
Number of Participants Who Discontinued Treatment Due to Adverse Events
Time frame: Baseline through end of study (at least Week 168)
The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event
Time frame: Baseline through end of study (at least Week 168)
The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).
Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities
Time frame: Baseline through end of study (at least Week 168)
The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.
Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
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.
Geometric Mean of Steady State Plasma APV Parameter: Cmax
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
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.
Median Steady State Plasma APV Tmax
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
tmax: time after administration of the drug when maximum concentration is reached
Geometric Mean of Steady State Plasma APV Parameter: CL/F
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
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.
Geometric Mean of Steady State Plasma APV Parameter: t1/2
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
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.
Least Squares Mean of Plasma APV Parameter: AUC0-tau
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
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.
Least Squares Mean of Plasma APV Parameter: Cmax
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
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.
Least Squares Mean of Plasma APV Parameter: Ctau
Time frame: 0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.
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.
4 secondary outcomes
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)
Time frame: Weeks 12, 48, 96, and 168
Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits
Time frame: Baseline and Weeks 12, 48, 96, and 168
Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits
Time frame: Baseline and Weeks 12, 48, 96, and 168
Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline
Time frame: Time of virologic failure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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
GlaxoSmithKline
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ritonavir and fosamprenavir in people with HIV Infection, run by ViiV Healthcare at 42 sites in 7 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 14 inclusion and 17 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, Italy, Portugal, Canada and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Feb 2010). 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 Who Discontinued Treatment Due to Adverse Events (time frame: Baseline through end of study (at least Week 168)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2017.