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View Clinical Trial (Medical Research Study)
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CNS Viral Dynamics and Cellular Immunity During AIDS - NCT00583167-37203 (Clinical Trial 197002)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy197002.aspx
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| City: |
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Nashville |
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State:
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TN |
| Zip Code: |
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37203 |
| Conditions: |
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HIV Infections |
| Purpose: |
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Understanding whether or not viral replication occurs in the brain during chronic untreated
HIV-1 infection is of undeniable importance, and has implications for treatment and research
priorities. Evidence suggests that viral replication in the CNS occurs at the extremes of
HIV-1 disease. Brain involvement has been reported during acute infection, and there is
convincing evidence of CNS viral replication during HIV-associated dementia (HAD) and
advanced AIDS. Some human and primate data suggest that viral RNA and proteins may be absent
from brains of some individuals with chronic untreated HIV-1 infection despite abundant
proviral DNA. However, the extent of viral replication in the brain is not known for most of
the 42 million people worldwide living with untreated HIV-1 infection.
Why is viral replication in the brain such a pivotal issue? Microglial cells and macrophages
are primary targets for intrathecal HIV-1 replication, and this can promote neuronal injury
through direct effects of gp120 and tat, and indirect induction of toxic mediators.
Low-grade injury over years or decades would likely be deleterious, particularly as the
population ages. Because treatment guidelines allow systemic HIV-1 replication to continue
until CD4+ T cell counts decline considerably, antiretroviral therapy (ART) is not
recommended for many persons living with HIV. Demonstrating replication in the brain during
chronic HIV-1 infection may affect treatment strategies and encourage investigation.
Identifying factors that modulate intrathecal viral replication is equally important.
Anti-HIV-1 cytotoxic T lymphocytes (CTL) partially control systemic viral replication and
delay disease progression. Although available data has been provocative, the role of
anti-HIV CTL in the CNS has received little attention. To fill this gap we will examine
relationships between intrathecal viral replication, CTL responses, and glial
activation/proliferation during HIV-1 infection. These studies will be relevant not only to
AIDS but to other inflammatory diseases of the CNS as well.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- (All subjects in Groups A1, A2 and B):
- At least 18 years of age.
- No more than one month of ART in the past.
- No ART in the previous 3 months.
- Platelet count >100,000 cells/mm3 on most recent determination within 60 days prior
to first study lumbar puncture.
- Normal prothrombin time (PT) and partial thromboplastin time (PTT) on most recent
determination within 60 days prior to first study lumbar puncture.
- Among individuals with past ART experience, the ability to construct an ART regimen
predicted to completely suppress plasma HIV-1 RNA, based on results of viral
susceptibility testing that is done as a routine part of clinical practice.
- Plasma HIV-1 RNA >20,000 copies/mL.
- Additional Inclusion Criteria for Groups A1 and A2.
- Group A1:
- CD4+ T cell count >200 cells/mm3.
- CSF HIV-1 RNA >2,000 copies/mL on screening lumbar puncture.
- No history of significant allergy to beta lactam antibiotics, including penicillins
and cephalosporins.
- No history of allergy to vancomycin.
- Group A2:
- CD4+ T cell count <200 cells/mm3.
- CSF HIV-1 RNA >2,000 copies/mL on screening lumbar puncture.
- No history of significant allergy to beta lactam antibiotics, including penicillins
and cephalosporins.
- No history of allergy to vancomycin.
Exclusion Criteria:
- Evidence of CNS opportunistic infections or space occupying lesion.
- History of significant CNS disorder unrelated to HIV infection such as trauma,
congenital malformations or genetic disorders.
- History of seizures.
- As determined by the investigator, a significant active or previous history of
cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric,
or endocrine disease(s) that would interfere with study participation.
- Evidence or suspicion of vascular or Alzheimer's type dementias.
- Evidence or suspicion of Parkinson's disease.
- History of allergy to lidocaine.
- Implanted metal objects that make MRI contraindicated. This may require consultation
with colleagues in the Vanderbilt Dept. of Radiology.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug
administration.
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an
adequate method of contraception to avoid pregnancy throughout the study in such a
manner that the risk of pregnancy is minimized.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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