Ignite Creation Date:
2024-05-05 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00614458
Status:
TERMINATED
Last Update Posted:
2011-10-25
First Post:
2008-01-31
Brief Title:
MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4 T Cell HIV Infection
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
10493 - MK-0518 Intensification and HDAC Inhibition in Depletion of Resting CD4 T Cell HIV Infection
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to insufficient funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments We will see if adding Raltegravir MK-0518 and Valproic acid VPA to current ART can decrease the amount of latent HIV
Detailed Description:
The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments Eradicating this hidden persistent virus which we will call latent HIV may some day allow HIV to be eliminated from an infected person Recently it has been discovered that a class of medicines called histone deacetylase HDAC inhibitors may cause the HIV that hides within some of the cells of your body to be expressed unmasked The HDAC inhibitor we will use in this study to unmask or flush out the latent HIV within your cells is called valproic acid VPA and is commonly used to treat seizures and depression under the brand name Depakote VPA has been safely given to people with HIV for the treatment of seizures or depression
In our first study we recruited 4 volunteers with HIV-1 infection taking antiviral therapy in whom there were 50 copiesml undetectable of HIV virus RNA in their blood for over 6 months In addition to continuing their anti-HIV medications we started them on Fuzeon a new injected anti-HIV medication for one month We then added VPA to the anti-HIV medications and Fuzeon for 3 months At the end of the study we found that latent HIV was significantly decreased No safety problems with VPA and antiviral medicines were noted However having initiated Fuzeon and VPA simultaneously we could not determine with confidence that our findings were due to the effect of VPA alone
In the next study we added VPA to the therapy of patients taking standard antiretroviral therapy ART Eight patients have been studied so far but only three have yet had a significant decrease in latent HIV It may be that VPA does not work in everyone or that stronger HIV therapy is needed in some people to drain latent HIV And in a different study no decrease at all was found in the number of infected cells in people taking ART who were prescribed valproate for other reasons
In this study we wish to add a different new anti-HIV medicine which is a pill Raltegravir MK-0518 Raltegravir blocks the virus from permanently entering the DNA of your T cells and so is called an integrase inhibitor Raltegravir is investigational This means the US Food and Drug Administration FDA have not yet approved it for sale We will see if adding Raltegravir and VPA to your current ART can decrease the amount of latent HIV If adding Raltegravir and VPA to your ART has no effect you will have reached the end of the study If adding Raltegravir and VPA decreases latent infection we will stop VPA but continue Raltegravir to see if this new integrase inhibitor decreases latent infection This study does not expect to cure your HIV but only to take the first step towards that far-away goal
You are asked to join this study because you are infected with the HIV-1 virus you are 18 years of age you are able and willing to sign an informed consent you are able to have laboratory tests within the study specific criteria and you have adequate vein access for leukopheresis
In our first study we recruited 4 volunteers with HIV-1 infection taking antiviral therapy in whom there were 50 copiesml undetectable of HIV virus RNA in their blood for over 6 months In addition to continuing their anti-HIV medications we started them on Fuzeon a new injected anti-HIV medication for one month We then added VPA to the anti-HIV medications and Fuzeon for 3 months At the end of the study we found that latent HIV was significantly decreased No safety problems with VPA and antiviral medicines were noted However having initiated Fuzeon and VPA simultaneously we could not determine with confidence that our findings were due to the effect of VPA alone
In the next study we added VPA to the therapy of patients taking standard antiretroviral therapy ART Eight patients have been studied so far but only three have yet had a significant decrease in latent HIV It may be that VPA does not work in everyone or that stronger HIV therapy is needed in some people to drain latent HIV And in a different study no decrease at all was found in the number of infected cells in people taking ART who were prescribed valproate for other reasons
In this study we wish to add a different new anti-HIV medicine which is a pill Raltegravir MK-0518 Raltegravir blocks the virus from permanently entering the DNA of your T cells and so is called an integrase inhibitor Raltegravir is investigational This means the US Food and Drug Administration FDA have not yet approved it for sale We will see if adding Raltegravir and VPA to your current ART can decrease the amount of latent HIV If adding Raltegravir and VPA to your ART has no effect you will have reached the end of the study If adding Raltegravir and VPA decreases latent infection we will stop VPA but continue Raltegravir to see if this new integrase inhibitor decreases latent infection This study does not expect to cure your HIV but only to take the first step towards that far-away goal
You are asked to join this study because you are infected with the HIV-1 virus you are 18 years of age you are able and willing to sign an informed consent you are able to have laboratory tests within the study specific criteria and you have adequate vein access for leukopheresis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI067854 | NIH | None | httpsreporternihgovquickSearchU01AI067854 |
| R01AI064074 | NIH | None | None |
| P30AI050410 | NIH | None | None |