PENTA Fosamprenavir Study

NCT01077635 | Completed

• 1 other identifier: 112880
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Infection, Human Immunodeficiency Virus

Keywords

HIV; Antiretroviral therapy; protease inbitor; fosamprenavir; paediatrics

Outcome Measures

Primary Outcomes (1)

• Number of children on licensed dose of FPV/RTV

  Assessed at 1, 2 and 3 years post exposure

Secondary Outcomes (2)

• Reason for stopping FPV

  Assessed at 1, 2 and 3 years post exposure

• Laboratory tests for absolute neutrophil counts (ANC), lipids (total cholesterol [TC] and triglycerides [TG]), and alanine transaminase (ALT)

  Assessed at 1, 2 and 3 years post exposure

Study Arms (1)

HIV-1 infected children aged 6 ≤ 18 years

HIV-1 infected children aged 6 ≤ 18 years currently or having ever been exposed to FPV/RTV; this is the indicated group for the licensed dose in the paediatric population.

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

Interventions

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

HIV-1 infected children currently or having ever been exposed to FPV (+/- 20% of 18mg/kg BID + RTV)

HIV-1 infected children aged 6 ≤ 18 years

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Seven paediatric HIV cohorts participating in the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) as follows: French Perinatal Cohort Study / Enquête Périnatale Français; Hospital St.Pierre Cohort, Brussels; Italian Register for HIV-infection in Children; Madrid Cohort of HIV-infected Children; Spanish Perinatal Cohort Study \[NENEXP\], Catalonia, Spain; UK National Study of HIV in Pregnancy and Childhood \[NSHPC\] \& Collaborative HIV Paediatric Study \[CHIPS\]; and the "Victor Babes" Hospital Cohort, Romania.

You may qualify if:

• HIV-1 infected children aged 6-18 years exposed to licensed paediatric dose of FPV/RTV January 1 2008 (or date of exposure to FPV if earlier to this but still exposed at 1/1/2008) from the participating cohorts

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

BID protein, human; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: October 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 1, 2017

Record last verified: 2012-01