Pilot study of simplification with fosamprenavir/ritonavir (FPV/r) monotherapy

ISRCTN	ISRCTN78584791
DOI	https://doi.org/10.1186/ISRCTN78584791
Protocol serial number	FONT Study-07
Sponsor	Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Funder	Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Submission date: 04/12/2008
Registration date: 23/12/2008
Last edited: 27/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Podzamczer
Scientific

HIV Unit
Infectious Disease Service
Hospital Universitari de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Phone	+34 93 26 07 668/667
Email	dpodzamczer@bellvitgehospital.cat

Study information

Primary study design	Interventional
Study design	Pilot, prospective one-arm non-comparative multicentre study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy: a pilot, prospective one-arm non-comparative multicentre study
Study acronym	FONT
Study objectives	Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy in patients with undetectable viral load will maintain virological suppression.
Ethics approval(s)	1. Ethics Committee of the Hospital Bellvitge gave approval on the 27th September 2007 (amendment 1 on 13th December 2007) 2. Spanish Drug Agency approved the trial on the 27th September 2007
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)
Intervention	Fosamprenavir/ritonavir 700/100 mg twice daily (BID). The duration of the study is 48 weeks. After the end of the study period, FPV/r monotherapy will be continued or not according to physicians criteria. 1. Discontinuation of nucleosides 2. Clinical and laboratory assessment at baseline and weeks 4, 8, 12, 16, 24, 32, 40 and 48. Tests include: blood cells, ALT, alkaline phosphatase, gamma-glutamyl transpeptidase (GGT), creatinine, triacylglycerol (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), glucose, CD4 and CD8, viral load. At weeks 8 and 16 only viral load). 3. Pharmacokinetics (PK) and viral load in cerebrospinal fluid (CSF) sample at 24 weeks; same for semen samples at 0, 24 and 48 weeks 4. Genotype resistance tests if patients with viral load greater than 500 copies/mL throughout the study period
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fosamprenavir/ritonavir (FPV/r)
Primary outcome measure(s)	Proportion of patients with plasma viral load less than 40 copies/mL at 48 weeks.
Key secondary outcome measure(s)	1. Viral load in CSF and semen, in CSF sample at 24 weeks and in semen samples at 0, 24 and 48 weeks 2. FPV levels in CSF and semen, in CSF sample at 24 weeks and in semen samples at 0, 24 and 48 weeks 3. Correlation between FPV plasma viral load and virological and immunological responses 4. Immunological outcome (CD4 and CD8) at weeks 0, 4, 12, 24, 32, 40 and 48 5. Lipid changes at weeks 0, 4, 12, 24, 32, 40 and 48 6. Adherence to therapy (GEEMA questionnaire), every visit
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Adult human immunodeficiency virus (HIV) infected patients (greater than 18 years, either gender) 2. Receiving a highly active anti-retroviral therapy (HAART) regimen including FPV/r (for at least four weeks) and two nucleoside/nucleotide analogues 3. Without previous failure with protease inhibitor regimens 4. Viral load less than 40 copies/mL for at least six months 5. CD4 counts greater than 100 cells/uL at inclusion
Key exclusion criteria	1. Previous virologic failure (confirmed or suspected) while receiving a PI-based regimen 2. Alanine aminotransferase (ALT) greater than 5 x upper limit of normal 3. Clinical suspicion of cirrosis 4. Renal insufficiency with glomerular filtrate less than 50 ml/min 5. Haemoglobin less than 9 g/dl 6. Neutrophils less than 1000/mm^3 7. Platelets less than 30,000 /mm^3 8. Pregnant women or no contraceptive measures 9. Active infection in the two weeks prior to inclusion in the study 10. Systemic therapy for neoplasms 11. Patients with positive hepatitis B surface antigens (HBsAg) receiving tenofovir and/or lamiduvine
Date of first enrolment	06/11/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Spain

Study participating centre

HIV Unit

Barcelona
08907
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes