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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00071760 |
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 |
Drug: GW433908 Drug: ritonavir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
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) |
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).
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Florida | |
GSK Investigational Site | Withdrawn |
Jacksonville, Florida, United States, 32209 | |
United States, New York | |
GSK Investigational Site | Withdrawn |
New York, New York, United States, 10016 | |
United States, North Carolina | |
GSK Investigational Site | Active, not recruiting |
Durham, North Carolina, United States, 27705 | |
Argentina | |
GSK Investigational Site | Terminated |
Buenos Aires, Argentina, 1405 | |
Mexico | |
GSK Investigational Site | Completed |
Mexico, Mexico, 6720 | |
GSK Investigational Site | Completed |
Mexico, D.F., Mexico, 06720 | |
Portugal | |
GSK Investigational Site | Terminated |
Almada, Portugal, 2805-267 | |
GSK Investigational Site | Terminated |
Lisboa, Portugal, 1649-035 | |
GSK Investigational Site | Withdrawn |
Amadora, Portugal, 2700 | |
Puerto Rico | |
GSK Investigational Site | Completed |
San Juan, Puerto Rico, 00935 | |
Russian Federation | |
GSK Investigational Site | Not yet recruiting |
Krasnojarsk, Russian Federation, 660049 | |
GSK Investigational Site | Recruiting |
Moscow, Russian Federation, 105275 | |
GSK Investigational Site | Recruiting |
Moscow, Russian Federation, 129110 | |
GSK Investigational Site | Recruiting |
St. Petersburg, Russian Federation, 196645 | |
South Africa | |
GSK Investigational Site | Recruiting |
Gauteng, South Africa, 2013 | |
South Africa, KwaZulu- Natal | |
GSK Investigational Site | Active, not recruiting |
Durban, KwaZulu- Natal, South Africa, 4013 | |
South Africa, Western Province | |
GSK Investigational Site | Recruiting |
Parow Valley, Western Province, South Africa, 7505 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | APV20002 |
Study First Received: | October 30, 2003 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00071760 |
Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
HIV protease inhibitors Lexiva fosamprenavir |
amprenavir AGENERASE ritonavir pediatrics |
Virus Diseases Amprenavir Sexually Transmitted Diseases, Viral Fosamprenavir Ritonavir |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |