HIV Infections
Conditions
Keywords
HIV
Brief summary
This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.
Interventions
DRUGetanercept
Sponsors
Immunex Corporation
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults greater than 18 years of age with documented HIV infection * Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks. * CD4 greater than 200 at time of study enrollment * Stable monitoring labs (hematology survey with differential, ALT, creatinine) * Absolute neutrophil count within normal limits
Exclusion criteria
* AIDS defining illness within the last 6 months * Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections * Women who are pregnant or nursing * Hypersensitivity to etanercept * Previous use of etanercept * Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma) * History of active or latent tuberculosis * History of demyelinating nerve disease * History of seizure disorder * Latex allergy * Subject has any of the following laboratory values within 30 days of baseline: * hemoglobin concentration \< 10.0 g/dl for men and \< 9.0 g/dl for women * platelet count \< 75,000/mm3 * AST or ALT \> 5x upper limit of normal (ULN) * serum creatinine \> 2.5x ULN * serum pancreatic amylase \> 1.5 ULN * Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon * Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in CD4 counts | — |
| changes in HIV-RNA levels | — |
Secondary
| Measure | Time frame |
|---|---|
| development of infections | — |
| degree of TNF inhibition by measuring TNF levels | — |
| changes in hematologic and biochemical laboratory tests | — |
Countries
United States
Outcome results
None listed