NCT00091741

Brief Summary

The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

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

First Submitted

Initial submission to the registry

September 16, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2004

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

July 22, 2009

Status Verified

September 1, 2004

First QC Date

September 16, 2004

Last Update Submit

July 21, 2009

Conditions

HIV Infection

Keywords

HIVTreatment ExperiencedComplementary Therapies

Interventions

Etanercept (Enbrel)DRUG

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 60 years.
  • Confirmed diagnosis of HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot at any time prior to study entry, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA.
  • Prior antiretroviral therapy, defined as: Receipt of at least two separate protease inhibitor (PI)-containing regimens (minimum 12 weeks) which was changed because of virological failure (per subject or physician history) or detectable plasma HIV-1 RNA AND A minimum of 1 year total prior antiretroviral experience.
  • A CD4 count of \> 200.
  • Signed a written informed consent prior to initiation of any study related procedures.
  • All subjects should continue taking the same antiretroviral regimen between the screening and entry visits.

You may not qualify if:

  • History or suspicion of active tuberculosis or a prior history of being treated for tuberculosis.
  • Documented history of sepsis.
  • Known hypersensitivity to ENBREL or any of its components.
  • Patients on concomitant immunosuppressive therapy, e.g., steroids, cyclosporine, etc.
  • Any condition which may interfere with the trial, including the patient's mental ability to follow protocol instructions.
  • Patients with heart failure or a history of congestive heart failure.
  • Renal insufficiency (creatinine \>2.5 mg/dL)
  • Women of child bearing potential who are not willing to avoid pregnancy for the duration of the study and 3 months thereafter.
  • Inability or unwillingness to take appropriate prophylaxis for opportunistic infections (i.e., PCP toxoplasmosis, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Related Publications (2)

  • De SK, Devadas K, Notkins AL. Elevated levels of tumor necrosis factor alpha (TNF-alpha) in human immunodeficiency virus type 1-transgenic mice: prevention of death by antibody to TNF-alpha. J Virol. 2002 Nov;76(22):11710-4. doi: 10.1128/jvi.76.22.11710-11714.2002.

    PMID: 12388730BACKGROUND

  • Zagury D, Burny A, Gallo RC. Toward a new generation of vaccines: the anti-cytokine therapeutic vaccines. Proc Natl Acad Sci U S A. 2001 Jul 3;98(14):8024-9. doi: 10.1073/pnas.141224798.

    PMID: 11438746BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Etanercept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2004

First Posted

September 20, 2004

Study Completion

October 1, 2004

Last Updated

July 22, 2009

Record last verified: 2004-09

Locations

US(1)