Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment
| City: |
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Long Beach |
| State: |
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California |
| Zip Code: |
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90822 |
| Conditions: |
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HIV Infection |
| Purpose: |
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The substitution of raltegravir for the NRTIs will result in some reversal of the long term
adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated
with the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained
virological response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely
result in continued virologic efficacy.
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| Study Summary: |
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A prospective, non-controlled, non-randomized, single center study of a treatment regimen of
a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor in combination with
raltegravir in patients with HIV-1 infection who have been, and continue to be, fully
controlled on a standard HAART regimen of a PI or an NNRTI plus 2 NRTIs, and the effect of
the change in regimen on peripheral fat distribution.
This pilot study will contain 30 patients who will be followed over a period of one year
starting from the date of the medication change from an NRTI-based regimen to a
raltegravir-based NRTI-sparing regimen. Potential changes in fat distribution (fat content
as assessed by fat volume) will be measured with serial MRI's of the thighs.
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| Criteria: |
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Inclusion Criteria:
1. HIV-1 positive
2. Any patient on a boosted PI plus 2 NRTIs.
3. Visual evidence peripheral fat wasting
4. HIV-1 viral load fully suppressed at least 9mths.
Exclusion Criteria:
1. Historical resistance to PI patient receiving
2. No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
3. No contraindications to serial MRI scanning.
4. No contraindications to utilization of raltegravir.
5. Not currently receiving any medications drug-drug interaction w/ raltegravir.
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| NCT ID: |
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NCT01164605 |
| Primary Contact: |
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Principal Investigator
Stephen M Berman, M.D., Ph.D.
Southern California Institute for Research and Education
Stephen M Berman, M.D.,Ph.D.
Phone: (562) 826-8000 ext. 2841
Email: stephen.berman2@va.gov
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| Backup Contact: |
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Email: judy.gerken@va.gov
Judy A Gerken, NP
Phone: (562) 826-8000 ext. 5452
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| Location Contact: |
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Long Beach, California 90822
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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