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| Name | Class |
|---|---|
| Vaccine and Gene Therapy Institute, Florida | OTHER |
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We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%
The investigators have previously shown that up to 40% of HAART-treated adults have suboptimal CD4 recovery despite viral suppression. The investigators have also shown that immune activation and exhaustion are significantly higher among patients that do not exhibit satisfactory rise in CD4 counts despite viral suppression (suboptimal responders); when compared with their counterparts with viral suppression and satifactory CD4 count recovery (optimal responders). Given that atorvastatin changes immune activation in this pilot study, then larger studies can be done to understand its effect on CD4 count increase among suboptimal responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atorvastatin, Lipitor® | Experimental | Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks. Peripheral blood mononuclear cells (PBMC) will be collected for immune activation assays using flowcytometry |
|
| Placebo | Placebo Comparator | Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin, Lipitor® | Other | PBMC collected for immune activation assays using flowcytometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily | Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated | 12 weeks |
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List of inclusion Criteria: HIV-infected adults on antiretroviral therapy for at least 6 years with sustained viral suppression (viral load<400 copies), and CD4 increase below 300 cells (difference between current and baseline CD4 count).
List of exclusion Criteria: History of an opportunistic infection within the previous six months, Pregnancy, History of myositis, History of ingestion of lipid-lowering agents at the baseline visit, Use of therapeutic agents known to have substantial drug-drug interactions with statins, and individuals on PI-containing HAART
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| Name | Affiliation | Role |
|---|---|---|
| Damalie Nakanjako, MD, PhD | Makerere University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21325137 | Background | Ganesan A, Crum-Cianflone N, Higgins J, Qin J, Rehm C, Metcalf J, Brandt C, Vita J, Decker CF, Sklar P, Bavaro M, Tasker S, Follmann D, Maldarelli F. High dose atorvastatin decreases cellular markers of immune activation without affecting HIV-1 RNA levels: results of a double-blind randomized placebo controlled clinical trial. J Infect Dis. 2011 Mar 15;203(6):756-64. doi: 10.1093/infdis/jiq115. Epub 2011 Feb 15. | |
| 21299909 |
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Participants were selected if they had sustained viral suppression for 7 years and CD4 increases below 300 cells/ul
30 participants were recruited from the Infectious Diseases Institute research cohort (single site) and followed up for 12 weeks, 4 weeks wash out period and 12 weeks after cross over of treatment assignment
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin First, Then Placebo | Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks. PBMC were collected for immune activation assays using flowcytometry 'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry |
| FG001 | Placebo First, Then Atorvastatin | Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry Placebo: PBMC were collected for immune activation assays using flowcytometry |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin First, Then Placebo | Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks. PBMC will be collected for immune activation assays using flowcytometry 'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily | Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated | There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin | Posted | Median | Inter-Quartile Range | percentage change in activated T-cells | 12 weeks |
|
12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin First, Then Placebo | Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks. PBMC were collected for immune activation assays using flowcytometry 'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | 3 myalgias were reported in atorvastatin and placebo groups |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Damalie Nakanjako | Makarere University | 41407000 | 249 | dnakanjako@gmail.com |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | PBMC collected for immune activation assays using flowcytometry |
|
|
| Background |
| Nakanjako D, Ssewanyana I, Mayanja-Kizza H, Kiragga A, Colebunders R, Manabe YC, Nabatanzi R, Kamya MR, Cao H. High T-cell immune activation and immune exhaustion among individuals with suboptimal CD4 recovery after 4 years of antiretroviral therapy in an African cohort. BMC Infect Dis. 2011 Feb 8;11:43. doi: 10.1186/1471-2334-11-43. |
| Placebo First, Then Atorvastatin |
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry Placebo: PBMC were collected for immune activation assays using flowcytometry |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4 T-cell activation | Median | Inter-Quartile Range | percenatage of activated CD4 T-cells |
|
| Placebo |
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry Placebo: PBMC were collected for immune activation assays using flowcytometry |
|
|
|
| 0 |
| 15 |
| 10 |
| 15 |
| EG001 | Placebo First, Then Atorvastatin | Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry Placebo: PBMC were collected for immune activation assays using flowcytometry | 0 | 15 | 9 | 15 |
|
| Chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| Joint pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| backache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| right forearm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |