CCRC: A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Raltegravir Therapy - NCT00661960-95814(Clinical Trial 216162)
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Sacramento |
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State:
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CA |
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95814 |
| Conditions: |
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HIV Infections - AIDS |
| Purpose: |
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This research is being done to study how the immune system in the small intestine improves
after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the
increase in the numbers of immune cells in the intestine to see if one type of HIV
medication gives different results than other types of HIV medications.
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| Study summary: |
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While the world-wide AIDS epidemic continues to impact millions of individuals, effective
anti-HIV medications have substantially reduced morbidity and mortality for those patients
able to adhere to combination regimens. Despite improved survival, durable virologic
suppression, and increases in peripheral CD4+T-cell counts in patients receiving potent
antiretroviral therapy (ART), immune reconstitution remains incomplete as measured by a
number of additional surrogate markers. Perhaps critically important among areas of
apparent incomplete immune recovery is the gastrointestinal-associated lymphoid tissue
(GALT), where CD4+T-cells repopulate very slowly, if at all. Raltegravir is a new ART agent
from a novel class of HIV inhibitors, integrase inhibitors, that results in rapid
suppression of HIV and recovery of peripheral CD4+T-cells. This project proposes to examine
whether volunteers receiving raltegravir recover GALT immune cells more completely than
those taking comparator ART. |
| Criteria: |
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Inclusion Criteria:
- willing to sign consent form
- no known GI pathology
- no anticipated antiretroviral therapy adjustments or changes
- males & females between the ages of 18 & 50 years
- no active opportunistic infections (OI) or therapy for OI within 30 days of entry
- can be on secondary prophylaxis with a history of AIDS defining illness
- per standard of care requirements, all females of child-bearing potential must agree
to use barrier methods to prevent pregnancy or be abstinent from activity while on
study
Exclusion Criteria:
- abnormal coagulation parameters (PT > or equal to 1.2 ULN)
- thrombocytopenia (platelet count < 50,000 within 6 weeks)
- contra-indications to upper endoscopy or conscious sedation
- anemia (> or equal to grade 1)
- aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation
cascade are prohibited within 1 week of endoscopy |
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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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September 22, 2010 |
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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