Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT00614458
Status:
TERMINATED
Last Update Posted:
2011-10-25
First Post:
2008-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
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:
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 copies/ml (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 U.S. 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 copies/ml (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 U.S. 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AI064074 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30AI050410 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AI067854 | NIH | None | https://reporter.nih.gov/quic… | View |