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| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2003 | ||||
| Last Updated Date | October 8, 2009 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Plasma APV (amprenavir) pharmacokinetic parameters following multiple dose administration of GW433908 BID or GW433908/RTV (ritonavir) BID. Incidence and nature of clinical and laboratory adverse events. [ Time Frame: 48 Weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Plasma APV (amprenavir) pharmacokinetic parameters following multiple dose administration of GW433908 BID or GW433908/RTV (ritonavir) BID; Incidence and nature of clinical and laboratory adverse events. | ||||
| Change History | Complete list of historical versions of study NCT00071760 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Proportions of subjects with plasma HIV-1 RNA levels <400 copies/mL at each study visit; change from baseline in percentage of CD4+ lymphocytes; plasma GW433908 concentrations; incidence of viral resistance; subject adherence. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects | ||||
| Official Title ICMJE | A 48 Week, Phase II, Open-label, 2-cohort, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of GW433908 and GW433908/RTV When Administered to HIV-1 Infected Protease Inhibitor (PI) Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to <2 Years. | ||||
| Brief Summary | This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old. |
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| Detailed Description | |||||
| 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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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Cohort 2 (4 weeks - <6 months): Subjects must be <6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort.
Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI). PI-experienced subjects defined as having prior experience 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 agent.
Exclusion Criteria:
Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been excluded for safety reasons). Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations).
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| Gender | Both | ||||
| Ages | up to 2 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Argentina, Mexico, Portugal, Puerto Rico, Russian Federation, South Africa | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00071760 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | APV20002 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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