NCT01902615

Brief Summary

This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2001

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

7.2 years

First QC Date

July 16, 2013

Last Update Submit

November 1, 2016

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml

    approximately 24 months

Secondary Outcomes (4)

  • Duration of treatment with Fuzeon

    approximately 24 months

  • Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml

    approximately 24 months

  • Safety: Incidence of adverse events

    approximately 24 months

  • Treatment regimen: Antiretroviral drugs used

    approximately 24 months

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with HIV-1 infection having received induction therapy with Fuzeon and antiretroviral drugs

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • HIV-1+ infection
  • Patients with a viral load \> 50 copies/ml who have received induction treatment with Fuzeon in combination with antiretroviral treatment
  • Naïve for Fuzeon at initiation of induction treatment
  • Antiretroviral treatment of at least 12 months duration

You may not qualify if:

  • Patients who did not receive Fuzeon treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barcelona, Barcelona, 08901, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 18, 2013

Study Start

January 1, 2001

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(1)