Tracking Information
Start Date ICMJE | July 2004 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 8, 2007) | Plasma APV Pharmacokinetics Incidence and nature of AEs and laboratory abnormalities Proportion of subjects who permanently discontinue 908/RTV or 908 due to AEs [ Time Frame: 48 Weeks ] |
Original Primary Outcome Measures ICMJE (submitted: January 5, 2006) | Plasma APV Pharmacokinetics; incidence and nature of AEs and laboratory abnormalities; proportion of subjects who permanently discontinue 908/RTV or 908 due to AEs |
Change History | Complete list of historical versions of study NCT00089583 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 11, 2007) |
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Original Secondary Outcome Measures ICMJE (submitted: January 5, 2006) | Plasma 908 concentrations; plasma RTV pharmacokinetic parameters; proportion of subjects with vRNA <400 copies/mL over time; changes in CD4+ cell counts over time; subject adherence; incidence of viral resistance |
Descriptive Information
Brief Title ICMJE | 48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection |
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Official Title ICMJE | See Detailed Description |
Brief Summary | This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection . |
Detailed Description | A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to <6 years old |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Condition ICMJE | HIV Infection |
Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 78 | ||||
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Estimated Completion Date | December 2012 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Agreement for 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 counseled and be willing to use one of the contraception methods listed below: Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide) 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. Hormonal contraception is not recommended, due to decreased efficacy of contraception as well as increased risk of hepatic transaminase elevation (see Section 8.2). All subjects of childbearing potential or developing child-bearing potential while participating in this study should be counseled on the practice of safe/safer sex.
Antiretroviral therapy (ART)-naïve or PI-naïve subjects (defined as having received less than one week of any PI and any length of therapy with NRTIs and/or NNRTIs). PI-experienced subjects (defined as having received greater than one week prior PI therapy with no more than three PIs). Prior RTV boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral age
Exclusion criteria:
Drugs whose plasma concentration may be increased to unsafe levels when co-administered with FPV including: Amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, and triazolam Drugs with the potential to significantly decrease plasma APV concentrations including: Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort.
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Gender | Both | ||||
Ages | 2 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Canada, Romania, Russian Federation, South Africa, Spain |
Administrative Information
NCT ID ICMJE | NCT00089583 | ||||
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Responsible Party | Study Director, GSK | ||||
Study ID Numbers ICMJE | APV29005 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline |