Condition category
Infections and Infestations
Date applied
04/12/2008
Date assigned
23/12/2008
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Podzamczer

ORCID ID

Contact details

HIV Unit
Infectious Disease Service
Hospital Universitari de Bellvitge
c/Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
+34 93 26 07 668/667
dpodzamczer@bellvitgehospital.cat

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FONT Study-07

Study information

Scientific title

Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy: a pilot, prospective one-arm non-comparative multicentre study

Acronym

FONT

Study hypothesis

Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy in patients with undetectable viral load will maintain virological suppression.

Ethics approval

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

Study design

Pilot, prospective one-arm non-comparative multicentre study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Fosamprenavir/ritonavir (FPV/r)

Primary outcome measures

Proportion of patients with plasma viral load less than 40 copies/mL at 48 weeks.

Secondary outcome measures

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

Overall trial start date

06/11/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

06/11/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Spain

Trial participating centre

HIV Unit
Barcelona
08907
Spain

Sponsor information

Organisation

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Sponsor details

c/Gran Vía s/n. Km 2.7
L'Hospitalet de Llobregat
Barcelona
08907
Spain
+34 93 26 07 642
proca@idibell.org

Sponsor type

Research organisation

Website

http://www.idibell.es

Funders

Funder type

Research organisation

Funder name

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21729229

Publication citations

  1. Results

    Saumoy M, Tiraboschi J, Gutierrez M, Niubó J, Domingo P, Vila A, Podzamczer D, Viral response in stable patients switching to fosamprenavir/ritonavir monotherapy (the FONT Study)., HIV Med., 2011, 12, 7, 438-441, doi: 10.1111/j.1468-1293.2010.00898.x.

Additional files

Editorial Notes