NCT00334022

Brief Summary

In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (\> 5 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

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

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

June 2, 2006

Last Update Submit

June 4, 2012

Conditions

HIV-1

Keywords

FuzeonViral Decay

Outcome Measures

Primary Outcomes (1)

  • The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.

    The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.

    6 months

Secondary Outcomes (8)

  • To determine the change of proviral HIV-1 DNA from baseline to month 3

    3 months

  • To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm

    9 months

  • To quantify plasma HIV (limit of detection 2 copies/ml of plasma)

    9 months

  • To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells

    9 months

  • To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays

    9 months

  • +3 more secondary outcomes

Study Arms (2)

Did not receive enfuvirtide

PLACEBO COMPARATOR

patients were randomized to either receive enfuviratide or not receive it

Drug: enfuvirtide

enfuvirtide

ACTIVE COMPARATOR

enfuvirtide 1ml BID

Drug: enfuvirtide

Interventions

enfuvirtideDRUG

1ml BID

Did not receive enfuvirtideenfuvirtide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient must be HIV infected
  • Patient must be \> 18 years old
  • Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
  • Patient must have a viral load \< 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
  • Patient must have a CD4 count above 400 cells/mm3 in last 3 months
  • Female patient must agree to use two methods of birth control or abstinence during the period of the study
  • Patient has to have signed full informed consent

You may not qualify if:

  • Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
  • Patient who have taken mono or dual antiretroviral therapy
  • Patient who have had a viral load \> 50 copies/mL on any antiretroviral regimen
  • Patient with any of the following abnormal laboratory test results in screening:
  • Hemaglobin \< 100 g/L
  • Neutrophil count \< 750 cells/uL
  • Platelet count \< 50,000 cells/L
  • AST or ALT \> 5X the upper limit of normal
  • Creatinine \> 250 umol/L
  • Patient with a malignancy
  • Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
  • Patient with an active AIDS-defining illnesses in the past six months
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maple Leaf Medical Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

MeSH Terms

Interventions

Enfuvirtide

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Colin Kovacs, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

January 1, 2010

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

CA(1)