Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367458
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2006-08-22
Brief Title:
Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Placebo Controlled Trial of Atorvastatin in HIV Positive Patients Not on Antiretroviral Medications With the Specific Aims of Studying the Effects of Atorvastatin on HIV Viral Load and Immune Activation Markers
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STATIN
Brief Summary:
This study will examine the effects of atorvastatin a statin drug that lowers cholesterol on the human immunodeficiency virus HIV If not treated HIV infection causes an incurable progressive deficiency in the immune system that leads to death usually from disease that takes advantage of weakened immunity Previous studies however have suggested that if the amount of cholesterol in infected cells is reduced multiplication of HIV is also reduced In this study researchers will examine the HIV viral loads that is amount of the virus in the blood They will evaluate the composition of the strain of the virus that patients carry HIV genotype response of the immune system to the virus and how genes may determine the way in which the drug may or may not work against the strain of virus Researchers plan to enroll 22 participants anticipating a study to last 30 weeks for each participant
Patients ages 18 or older with HIV infection who are not pregnant or breastfeeding who do not have a known allergy to atorvastatin use and who have not had a serious illness or infection that required hospitalization within the 30 days before entering the study may be eligible for this study They will be assigned to random groups one that to receive atorvastatin and the other to receive a placebo which has no effect on cholesterol or ability of the HIV infection to multiply Patients will remain in their groups and treatments for 8 weeks At the completion of 8 weeks no matter the study group all patients will be required to discontinue all study-related medications for 4 weeks After that period the study assignments will be switched so that those previously taking the placebo will take atorvastatin and vice versa The study will proceed for another 8 weeks followed by a period of stopping study-related medications and patients being observed for 4 weeks Throughout the study patients will have regularly scheduled visits at the clinic At those visits there will be collection of blood samples assessments of symptoms physical examinations and questionnaires to complete Blood tests may require fasting beforehand and blood samples will be used in standard tests including those regarding the liver kidneys muscles blood cells and pregnancy status Specialized blood tests will determine viral load effects of the drug on the immune cells and genetic influence on the drugs effectiveness
Patients ages 18 or older with HIV infection who are not pregnant or breastfeeding who do not have a known allergy to atorvastatin use and who have not had a serious illness or infection that required hospitalization within the 30 days before entering the study may be eligible for this study They will be assigned to random groups one that to receive atorvastatin and the other to receive a placebo which has no effect on cholesterol or ability of the HIV infection to multiply Patients will remain in their groups and treatments for 8 weeks At the completion of 8 weeks no matter the study group all patients will be required to discontinue all study-related medications for 4 weeks After that period the study assignments will be switched so that those previously taking the placebo will take atorvastatin and vice versa The study will proceed for another 8 weeks followed by a period of stopping study-related medications and patients being observed for 4 weeks Throughout the study patients will have regularly scheduled visits at the clinic At those visits there will be collection of blood samples assessments of symptoms physical examinations and questionnaires to complete Blood tests may require fasting beforehand and blood samples will be used in standard tests including those regarding the liver kidneys muscles blood cells and pregnancy status Specialized blood tests will determine viral load effects of the drug on the immune cells and genetic influence on the drugs effectiveness
Detailed Description:
This protocol is a randomized double blind placebo controlled trial designed to study the effects of the lipid lowering statin atorvastatin on HIV-1 viremia
Untreated HIV-1 infection results in an incurable progressive immunodeficiency and death usually from opportunistic infections Combination antiretroviral therapy ARV has been successful in suppressing HIV replication and reducing morbidity and mortality Long term ARV therapy is associated with the development of HIV-1 drug resistance and significant adverse side effects including metabolic and cardiovascular complications Prolonged therapy with certain antiretrovirals is associated with increased risk of cardiovascular disease and a number of dyslipidemic syndromes including increased levels of cholesterol LDL and triglycerides in peripheral blood New therapeutic strategies to suppress HIV-1 infection are essential
Previously in vitro studies suggested that exposure to cholesterol-lowering statins results in decreases in HIV-1 replication The mechanisms of inhibition remain uncertain but possibilities include disrupting membrane trafficking or cytoskeletal processes necessary for intracellular transport of viral proteins or altering cellular activation state necessary for viral gene expression Initial in vivo studies of the effects of statins on HIV-1 have been largely anecdotal in nature and have yielded conflicting results Although statin therapy is commonly used in HIV-1 infection adverse effects from the combination of antiretrovirals and statins are possible A more thorough understanding of the effects of statins on HIV-1 replication is essential to determine the potential therapeutic effect and to investigate the risks and benefits of this approach in vivo
We plan to conduct a double blind randomized placebo controlled trial with a cross over design to study the effects of atorvastatin in 22 HIV-infected patients not currently taking antiretroviral therapy Patients will be randomized to receive either placebo or atorvastatin 80mg for 8 weeks After a 4-week wash out period patients on the atorvastatin arm will crossover to placebo and vice versa patients in the placebo arm will cross over to atorvastatin for an additional 8 weeks Upon completion of study medications all patients will be followed for 4 weeks Each arm will have a minimum of 11 patients each The primary outcome measure in this study is the effect of lipid lowering agents on HIV-1 RNA levels additional secondary outcome measures include effects of lipid lowering agents on lipid profile markers of inflammation and immune activation and investigations of host and viral genetic factors
Untreated HIV-1 infection results in an incurable progressive immunodeficiency and death usually from opportunistic infections Combination antiretroviral therapy ARV has been successful in suppressing HIV replication and reducing morbidity and mortality Long term ARV therapy is associated with the development of HIV-1 drug resistance and significant adverse side effects including metabolic and cardiovascular complications Prolonged therapy with certain antiretrovirals is associated with increased risk of cardiovascular disease and a number of dyslipidemic syndromes including increased levels of cholesterol LDL and triglycerides in peripheral blood New therapeutic strategies to suppress HIV-1 infection are essential
Previously in vitro studies suggested that exposure to cholesterol-lowering statins results in decreases in HIV-1 replication The mechanisms of inhibition remain uncertain but possibilities include disrupting membrane trafficking or cytoskeletal processes necessary for intracellular transport of viral proteins or altering cellular activation state necessary for viral gene expression Initial in vivo studies of the effects of statins on HIV-1 have been largely anecdotal in nature and have yielded conflicting results Although statin therapy is commonly used in HIV-1 infection adverse effects from the combination of antiretrovirals and statins are possible A more thorough understanding of the effects of statins on HIV-1 replication is essential to determine the potential therapeutic effect and to investigate the risks and benefits of this approach in vivo
We plan to conduct a double blind randomized placebo controlled trial with a cross over design to study the effects of atorvastatin in 22 HIV-infected patients not currently taking antiretroviral therapy Patients will be randomized to receive either placebo or atorvastatin 80mg for 8 weeks After a 4-week wash out period patients on the atorvastatin arm will crossover to placebo and vice versa patients in the placebo arm will cross over to atorvastatin for an additional 8 weeks Upon completion of study medications all patients will be followed for 4 weeks Each arm will have a minimum of 11 patients each The primary outcome measure in this study is the effect of lipid lowering agents on HIV-1 RNA levels additional secondary outcome measures include effects of lipid lowering agents on lipid profile markers of inflammation and immune activation and investigations of host and viral genetic factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0197 | OTHER | NIAID IRB | None |