Topics

PENTA Fosamprenavir Study

2014-08-27 03:15:35 | BioPortfolio

Summary

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events were the most commonly reported AEs, but that the majority of events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was reported in 20% of children in the APV20003 trial; and neutropenia was identified as a potential safety concern by the European Medicines Agency (EMEA). The objectives of this study were to conduct an observational cohort study of the usage and safety of FPV/RTV in children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Infection, Human Immunodeficiency Virus

Intervention

Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:35-0400

Clinical Trials [4131 Associated Clinical Trials listed on BioPortfolio]

Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biolo...

3BNC117 and 10-1074 in HIV Uninfected Adults

This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074, when ...

Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg s...

Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV

Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to ...

A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naiv...

PubMed Articles [26113 Associated PubMed Articles listed on BioPortfolio]

Burden of Co-Infection: A Cost Analysis of Human Immunodeficiency Virus in a Commercially Insured Hepatitis C Virus Population.

In patients with hepatitis C virus (HCV), human immunodeficiency virus (HIV) represents a major cause of morbidity and economic burden. Economic evaluations in HIV-HCV typically focus on government-sp...

Mucocutaneous manifestations of human immunodeficiency virus (HIV) infection in children in relation to the degree of immunosuppression.

Human immunodeficiency virus (HIV) infection in children is becoming a common occurrence. Worldwide, limited studies have been done on the mucocutaneous manifestations in HIV-positive children. The ai...

Effect of Hepatitis C Virus Coinfection on the Progression of Vertically Acquired Human Immunodeficiency Virus Infection During Childhood and Adolescence.

Data for a total of 57 patients vertically coinfected with human immunodeficiency virus (HIV)/hepatitis C virus (HCV) and 365 HIV-monoinfected patients were compared until their transition to adult ca...

Relapsing polychondritis in human immunodeficiency virus.

Relapsing polychondritis (RP) is an inflammatory condition that has been widely accepted as autoimmune in nature and can occur in patients with immune system dysregulation. Although RP has been well d...

Correlates Associated With Willingness to Start Pre-exposure Prophylaxis Among Young Black Men Who Have Sex With Men (MSM) in Jackson, Mississippi.

Black men who have sex with men have the greatest risk for human immunodeficiency virus infection. Pre-exposure prophylaxis (PrEP) is a highly effective prevention method. However, uptake in this grou...

Medical and Biotech [MESH] Definitions

Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

More From BioPortfolio on "PENTA Fosamprenavir Study"

Quick Search

Relevant Topic

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial