A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00296504

Purpose

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

Condition	Intervention	Phase
HIV Infection	Drug: fosamprenavir (GW433908) Drug: ritonavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir VX 478 Fosamprenavir Fosamprenavir calcium Fosamprenavir sodium Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The study endpoints are the incidence and frequency of adverse events and laboratory abnormalities

Secondary Outcome Measures:

This study has no secondary outcome measures.

Enrollment:	700
Study Start Date:	November 2001

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion Criteria:

Permanent discontinuation of GW433908 in a previous study due to intolerance.
An active CDC Class C Event.
Any condition which, in the opinion of the investigator, would preclude a subject from participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296504

Show 154 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	APV30005
Study First Received:	February 24, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00296504
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW433908
pro-drug
amprenavir
fosamprenavir
LEXIVA

AGENERASE
protease inhibitor
HIV-1
antiretroviral therapy
antiretroviral therapy naive subjects

Study placed in the following topic categories:

Virus Diseases
Amprenavir
Sexually Transmitted Diseases, Viral
Fosamprenavir
Ritonavir

HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009