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| Sponsor: | ViiV Healthcare |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00071760 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Infection, Human Immunodeficiency Virus |
Drug: GW433908 Drug: ritonavir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A - 4weeks - less than 2yrs old (FPV/RTV bid)
Cohort 2A - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID) Cohort 1A - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID) |
Drug: GW433908
Fosamprenavir suspension bid
Drug: ritonavir
Ritonavir solution bid
Other Names:
|
|
Experimental: Arm B- 4weeks - less than 2yrs old (FPV bid)
Cohort 2B - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID) Cohort 1B - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID) |
Drug: GW433908
Fosamprenavir suspension bid
|
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.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| United States, North Carolina | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| Argentina | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, 1405 | |
| Mexico | |
| GSK Investigational Site | |
| Mexico, Mexico, 6720 | |
| GSK Investigational Site | |
| Mexico, D.F., Mexico, 06720 | |
| Portugal | |
| GSK Investigational Site | |
| Almada, Portugal, 2805-267 | |
| GSK Investigational Site | |
| Lisboa, Portugal, 1649-035 | |
| Puerto Rico | |
| GSK Investigational Site | |
| San Juan, Puerto Rico, 00935 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129110 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 105275 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 196645 | |
| South Africa | |
| GSK Investigational Site | |
| Parow Valley, Western Province, South Africa, 7505 | |
| GSK Investigational Site | |
| Soweto, South Africa, 2013 | |
| Study Director: | GSK Clinical Trials | ViiV Healthcare |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00071760 History of Changes |
| Other Study ID Numbers: | APV20002 |
| Study First Received: | October 30, 2003 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines United States: Food and Drug Administration |
|
pediatrics ritonavir amprenavir AGENERASE |
HIV Lexiva protease inhibitors fosamprenavir |
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Protease Inhibitors |
Ritonavir Fosamprenavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |