NCT01222611

Brief 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. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 30, 2014

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

October 15, 2010

Last Update Submit

May 29, 2014

Conditions

Chronic HIV InfectionHCV Coinfection

Keywords

HIVHCVHIV/HCVCoinfectionFosamprenavir

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 weeks

Study Arms (2)

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

Drug: Fosamprenavir

Interventions

FosamprenavirDRUG

HAART including fosamprenavir boosted with ritonavir

Also known as: Telzir(r)
HAART inlcuding Fos APV/r

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Coinfection

Interventions

fosamprenavir

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Juan Gonzalez, MD

    Hospital La Paz, Madrid (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 30, 2014

Record last verified: 2013-09

Locations

ES(6)