Chronic HIV InfectionPhase 4FOSTER-CNCT01222611
HCV Evolution in HIV/HCV (Genotype 1) Coinfected Patients Treated With Fosamprenavir
A Phase 4 study testing Fosamprenavir in people with Chronic HIV Infection and HCV Coinfection, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.
Trial summary
This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic HIV Infection, HCV Coinfection
- What is being tested?
- Fosamprenavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesSpain
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 yo
- HIV/HCV co-infected patients with HCV detectable viremia in 2 determinations separated at least by 6 months.
- HCV genotype 1
- Currently receiving ART including 2NRTI+1 PI/r (excluding FPV) or 1 NNRTI, without changes in the last 6 months
- HIV RNA < 50 copies/mL for the last 6 months
Who cannot join
- Previous anti HCV treatment
- Foreseeable HCV treatment in the next 12 months
- Acute HCV infection
- Active opportunistic infection
- HIV with FPV resistance mutations
- Current or previous treatment with FPV
- Chronic hepatitis B
- Current alcohol consumption greater than 20 g per day
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital La Paz
Madrid, Madrid, 28046
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Doce de Octubre
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
About this study
Official title: Randomized, Controlled, Open Label, Pilot Study to Evaluate Fosamprenavir Activity on Genotype 1 Hepatitis C Virus (HCV) Infection Evolution in Human Immunodeficiency Virus (HIV) Co-infected Subjects With Antiretroviral Treatment Including Fosamprenavir
This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.
- Conditions
- Chronic HIV Infection, HCV Coinfection
- Being tested
- Fosamprenavir
- Keywords
- HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir
- Medical subject headings
- Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosamprenavirDrug
Also called Telzir(r)
HAART including fosamprenavir boosted with ritonavir
| Study group | Role | What they receive |
|---|---|---|
| Standard HAART | No intervention | ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI |
| HAART inlcuding Fos APV/r | Experimental | ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir Receives: Drug: Fosamprenavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Viral load and changes in HCV protease gene
Undetectable HCV viral load. It will be considered that one patient achieves this endpoint if he/she has an undetectable HCV viral load (<30 copies/mL) at any time during the study. If a patient shows undetectable HCV viral load and afterwards shows a detectable load, it will be considered that this patient achieved this endpoint.
Changes in the HCV protease gen. Any change from baseline in the protease catalytic domain, analysed by population sequencing of the catalytic domain of the HCV protease.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Juan Gonzalez, MD, Principal investigator, Hospital La Paz, Madrid (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222611
- Sponsor's protocol ID
- GESIDA 6710
- Other IDs
- 2010-023503-10
- Acronym
- FOSTER-C
- Status last verified
- Sep 2013
- First submitted
- 15 Oct 2010
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open Label, Pilot Study to Evaluate Fosamprenavir Activity on Genotype 1 Hepatitis C Virus (HCV) Infection Evolution in Human Immunodeficiency Virus (HIV) Co-infected Subjects With Antiretroviral Treatment Including Fosamprenavir
- ClinicalTrials.gov ID
- NCT01222611
- Acronym / sponsor ID
- FOSTER-C / GESIDA 6710
- Conditions
- Chronic HIV Infection, HCV Coinfection
- Keywords
- HIV, HCV, HIV/HCV, Coinfection, Fosamprenavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard HAART | No intervention | –ART with 3 drugs including 2 NRTIs plus a ritonavir boosted PI (different to FPV) or a NNRTI |
| HAART inlcuding Fos APV/r | Experimental | Drug: FosamprenavirART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 yo
- HIV/HCV co-infected patients with HCV detectable viremia in 2 determinations separated at least by 6 months.
- HCV genotype 1
- Currently receiving ART including 2NRTI+1 PI/r (excluding FPV) or 1 NNRTI, without changes in the last 6 months
- HIV RNA < 50 copies/mL for the last 6 months
Key exclusion criteria (8 listed)
- Previous anti HCV treatment
- Foreseeable HCV treatment in the next 12 months
- Acute HCV infection
- Active opportunistic infection
- HIV with FPV resistance mutations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FosamprenavirAlso: Telzir(r)HAART including fosamprenavir boosted with ritonavir | Drug | HAART inlcuding Fos APV/r |
Primary outcome
HCV Viral load and changes in HCV protease gene
Time frame: 48 weeks
Undetectable HCV viral load. It will be considered that one patient achieves this endpoint if he/she has an undetectable HCV viral load (<30 copies/mL) at any time during the study. If a patient shows undetectable HCV viral load and afterwards shows a detectable load, it will be considered that this patient achieved this endpoint. Changes in the HCV protease gen. Any change from baseline in the protease catalytic domain, analysed by population sequencing of the catalytic domain of the HCV protease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Gonzalez, MD principal investigator
Hospital La Paz, Madrid (Spain)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosamprenavir in people with Chronic HIV Infection and HCV Coinfection, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Viral load and changes in HCV protease gene (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.