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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00089583 |
Purpose
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 .
| Condition | Intervention | Phase |
|---|---|---|
|
Infection, Human Immunodeficiency Virus I HIV Infection |
Drug: LEXIVA (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: | See Detailed Description |
| Estimated Enrollment: | 78 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2 - 18 yrs old (FPV/RTV BID)
Cohort 1B - 2 - less than 6yrs old (FPV/RTV BID) Cohort 2 - 6 to less than 12 yrs old (FPV/RTV BID) Cohort 3 - 12 - 18 yrs old (FPV/RTV BID) Cohort 4 - 2 - 18 yrs (FPV/RTV BID)
|
Drug: LEXIVA (GW433908)
Fosamprenavir suspension or tablet bid
Drug: Ritonavir
Ritonavir solution bid
Other Names:
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|
Experimental: 2 - less than 6yrs old (FPV BID)
2 - less than 6yrs old (FPV BID)
|
Drug: LEXIVA (GW433908)
Fosamprenavir suspension or tablet bid
|
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
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: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
A female is eligible to enter and participate in this study if she is of:
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.
Contacts and Locations
Show 39 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00089583 History of Changes |
| Other Study ID Numbers: | APV29005 |
| Study First Received: | August 6, 2004 |
| Last Updated: | November 11, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines United States: Food and Drug Administration |
|
antiretroviral therapy pediatrics AGENERASE amprenavir |
fosamprenavir ritonavir protease inhibitor LEXIVA |
|
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 Ritonavir |
Fosamprenavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |