Pilot study of simplification with fosamprenavir/ritonavir (FPV/r) monotherapy
| ISRCTN | ISRCTN78584791 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78584791 |
| Secondary identifying numbers | FONT Study-07 |
- 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
Not provided at time of registration
Contact information
Dr Daniel Podzamczer
Scientific
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 |
|---|---|
| dpodzamczer@bellvitgehospital.cat |
Study information
| Study design | Pilot, prospective one-arm non-comparative multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy: a pilot, prospective one-arm non-comparative multicentre study |
| Study acronym | FONT |
| Study hypothesis | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fosamprenavir/ritonavir (FPV/r) |
| Primary outcome measure | 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 study start date | 06/11/2007 |
| Overall study end date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
Study participating centre
HIV Unit
Barcelona
08907
Spain
08907
Spain
Sponsor information
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Research organisation
Research organisation
c/Gran Vía s/n. Km 2.7
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| Phone | +34 93 26 07 642 |
|---|---|
| proca@idibell.org | |
| Website | http://www.idibell.es |
"ROR" |
https://ror.org/0008xqs48 |
Funders
Funder type
Research organisation
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
