Understanding GWI: Integrative Modeling

• Status: Recruiting
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: Male

Summary

The investigator proposes to perform a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept followed by mifepristone for veterans with Gulf War Illness. The investigator will conduct and repeat the exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and the dynamic model identified in prior studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South Florida Veterans Affairs Foundation for Research and Education
• Collaborators: Nova Southeastern University; United States Department of Defense
• Treatments: Etanercept; Mifepristone

Criteria

Inclusion Criteria:

• Male Veterans who were deployed in 1990 -1991 Gulf War.

• Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.

• Veterans who were in good health based on medical history prior to 1990.

• Veterans who are between 40 to 70 years old

• Veterans who currently do not have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity.

Exclusion Criteria:

• Major depression with psychotic or melancholic features

• Schizophrenia

• Bipolar disorder

• Delusional disorders

• Dementias of any type

• History or current alcohol abuse

• History or current drug abuse

• Organ failure

• Transplant

• Defined rheumatologic

• Inflammatory disorders

• HIV

• Hepatitis B and C

• Primary sleep disorders

• Steroids

• Immunosuppressives

• Medications that impact immune function such as Enbrel or Methotrexate

• Tuberculosis or past history of tuberculosis exposure, as documented by PPD positivity