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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| Case Western Reserve University | OTHER |
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This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort
This is a randomized, open-label trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART-Atorvastatin adjunct therapy | Experimental | ART, atorvastatin |
|
| ART-Rosuvastatin adjunct therapy | Experimental | ART, rosuvastatin |
|
| ART-without statin adjunct therapy | Experimental | ART, no statin |
|
| Healthy-HIV-negative | Experimental | Age-matched HIV-negative, healthy volunteers from the same community |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART, Atorvastatin | Drug | ART, Atorvastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05) | measured by percentage of HLADR+CD38+T-cells | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05) | Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with dyslipidemia and eligible to receive or already receiving statin therapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damalie Nakanjako, PhD | Contact | +256772411273 | dnakanjako@gmail.com | |
| Rose Nabatanzo, MSC | Contact | +256772603646 | rosemagala@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Damalie Nakanjako, PhD | Makerere University College of Health Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25514794 | Result | Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478. | |
| 25441397 |
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Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ART, Rosuvastatin | Drug | ART, Rosuvastatin |
|
|
| ART, No statin | Drug | ART, No statin |
|
|
| Healthy-HIV-negative | Drug | Age-matched, Healthy HIV-negative |
|
|
| 36 months |
| Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05) | Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml | 36 months |
| Biological pathways affected by atorvastatin and rosuvastatin | number of genes down-regulated by either atorvastatin or rosuvastatin | 36 months |
| Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |