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fosamprenavir+ ritonavir+ methadone

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Feb 23, 2009

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

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Clinical trial landscape

fosamprenavir+ ritonavir+ methadone · 1 trial · 1 indication

Phase 1 1
NCT00481182Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.Healthy Subjects
COMPLETED20 Analytics
PHASE1COMPLETED
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
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Study Endpoints

Primary Endpoints

Serial blood samples will be collected over 24 hours for measurement of plasma (R-) and (S-) methadone (days 4 and 18) and serum amprenavir concentrations (day 18).

Secondary Endpoints

On study days 4, 11, and 18, opioid effects will be assessed pre-dose, 2 hours, and 6 hours following methadone dosing. Pharmacokinetic and opioid pharmacodynamic parameters will be compared between the two treatments.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
fosamprenavir + ritonavir + methadoneDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subject is enrolled in a certified methadone maintenance program for at least 12 weeks prior to Period 1, Day 1. Subject is receiving methadone = 200mg QD that has remained unchanged for 30 days The subject is male, female and is between the age of 18 and 64 years of age. A ...

Countries:United States
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Frequently asked questions about fosamprenavir+ ritonavir+ methadone

What is Fosamprenavir used for?

Fosamprenavir is an investigational small molecule being developed for the treatment of HIV infections, including HIV-1 infection in adults and pediatric subjects. It is studied in combination with other antiretroviral agents such as ritonavir, TRIZIVIR, or COMBIVIR. The drug is in Phase 3 clinical development for these indications.

Who makes Fosamprenavir?

Fosamprenavir is being developed by GSK plc, which trades under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections across various patient populations, including pediatric subjects aged 2 to 18 years and adults.

What does Fosamprenavir target?

Fosamprenavir is a protease inhibitor that targets the HIV protease enzyme, which is essential for viral replication. By inhibiting this enzyme, the drug aims to prevent the maturation of infectious viral particles. It is being studied in combination with other antiretroviral medications for the treatment of HIV-1 infection.

What phase is Fosamprenavir in?

Fosamprenavir is in Phase 3 clinical development for the treatment of HIV infections. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in various patient populations, including treatment-naive adults and pediatric subjects.

What clinical trials is Fosamprenavir in?

Fosamprenavir has been studied in several completed clinical trials, including NCT00040664 in pediatric subjects, NCT00043888 in adolescents and adults, NCT00094523 comparing it to other protease inhibitors, and NCT00450580 evaluating once-daily versus twice-daily dosing in treatment-naive adults. These trials enrolled a total of 753 participants.

Is Fosamprenavir the same as other HIV drugs?

Fosamprenavir is a distinct protease inhibitor used in combination with other antiretroviral agents. It is not the same as other HIV drugs, but it is often studied alongside medications like ritonavir, TRIZIVIR, and COMBIVIR to enhance its effectiveness. Its unique chemical structure and mechanism differentiate it from other protease inhibitors.