Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640192
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial Phase II Multicenter Open-label Randomized and Controlled Trial to Eliminate the Latent Reservoir of HIV-1 by Administering High Doses of Antiretroviral Drugs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The HIV epidemic represents one of the greatest health challenges worldwide with important social and economic implications for public health Although combination antiretroviral therapy TAR is effective in controlling infection and delaying disease onset as well as improving the quality of life of infected persons the relevant medical needs caused by HIV-1 infection are not yet fully met by TAR The main obstacle to curing HIV is the establishment and maintenance of the viral reservoir Therefore we believe that this clinical trial will provide knowledge for the first time of the increase of antiretroviral drug levels in lymphatic tissue achieved by simultaneous administration of antiretroviral drugs at higher than usual doses and their effect on persistent viral replication in intestinal lymphatic tissue and as a consequence on the latent cellular reservoir of HIV
Detailed Description:
Data on the penetration of antiretrovirals into the tissues of long-term treated HIV patients are very limited Previous pharmacokinetic studies indicate that tissue concentrations of the drug are much lower than those observed in plasma of HIV-infected patients or healthy volunteers In addition another study has reported that intracellular levels of antiretrovirals are much lower in lymphoid tissues than in peripheral blood after 6 months of TAR initiation and these levels correlated inversely with ongoing viral replication
In the line of research that we are raising a previous study has reported a decrease in intracellular HIV RNA in lymphoid tissue when dolutegravir was administered at higher than usual doses This is an important advance and new studies should be implemented with a design that allows to potentiate this strategy and significantly decrease the size of the viral reservoir in tissues
If the hypothesis of the project which consists mainly in the reduction or elimination of the HIV reservoir is demonstrated there would be very important consequences in the area of functional cure of HIV andor reduction of chronic persistent inflammation which could generate changes in conventional treatment schemes with great scalability In addition it is possible that by decreasing levels of persistent viral replication an improvement in levels of immune activation and inflammation may also be observed which would contribute positively to the overall health of the patient Oral antiretroviral medication is proposed in order to compound a three-drug antiretroviral regimen The three antiretroviral drugs have been chosen because they are the only ones that allow administration at higher doses without causing increased toxicity dolutegravir 50 mg12 h maraviroc 300 mg12 h and lamivudine 300 mg12 h
In the line of research that we are raising a previous study has reported a decrease in intracellular HIV RNA in lymphoid tissue when dolutegravir was administered at higher than usual doses This is an important advance and new studies should be implemented with a design that allows to potentiate this strategy and significantly decrease the size of the viral reservoir in tissues
If the hypothesis of the project which consists mainly in the reduction or elimination of the HIV reservoir is demonstrated there would be very important consequences in the area of functional cure of HIV andor reduction of chronic persistent inflammation which could generate changes in conventional treatment schemes with great scalability In addition it is possible that by decreasing levels of persistent viral replication an improvement in levels of immune activation and inflammation may also be observed which would contribute positively to the overall health of the patient Oral antiretroviral medication is proposed in order to compound a three-drug antiretroviral regimen The three antiretroviral drugs have been chosen because they are the only ones that allow administration at higher doses without causing increased toxicity dolutegravir 50 mg12 h maraviroc 300 mg12 h and lamivudine 300 mg12 h
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