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Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
Phase 2 trial testing Atorvastatin in HIV in 24 participants. Completed in 19 June 2008.
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 18 October 2006 |
| Primary completion | 19 June 2008 |
| Estimated completion | 19 June 2008 |
| Sites | 3 locations across United States |
National Institute of Allergy and Infectious Diseases (NIAID)
18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The change in HIV viral RNA level in plasma in response to lipid lowering agents was measured as log10 plasma RNA copy number, and the change in the log10 viral RNA level is included in table.
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | 0 | 0 – 0 |
| Placebo | 0 | 0 – 0 |
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | -0.03 | -0.35 – 0.04 |
| Placebo | -0.08 | -0.25 – 0.08 |
CD4+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | 0 | ± 5.34 |
| Placebo | 0 | ± 7.35 |
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | -2 | ± 5.05 |
| Placebo | -1.8 | ± 10.2 |
Here is the count of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | 12 | |
| Placebo | 12 |
CD8+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | 0 | ± 10.28 |
| Placebo | 0 | ± 12.52 |
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | -3.8 | ± 8.80 |
| Placebo | -3.5 | ± 12.15 |
CD8+HLADR+CD38+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | 0 | ± 12.31 |
| Placebo | 0 | ± 11.01 |
| Group | Value | 95% CI |
|---|---|---|
| Atorvastatin | -3.75 | ± 10.37 |
| Placebo | -3.3 | ± 13.28 |
Time frame: Date treatment consent signed to date off study, approximately 26 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Atorvastatin | Placebo |
|---|---|---|---|
| low LDL | Metabolism and nutrition disorders | — | — |
| Reaction | System | Atorvastatin | Placebo |
|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Abscess | Skin and subcutaneous tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Ear infection | Ear and labyrinth disorders | — | — |
| Electrocardiogram abnormal | Cardiac disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Herpes simplex | Skin and subcutaneous tissue disorders | — | — |
| Hot flush | Skin and subcutaneous tissue disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Pain | General disorders | — | — |
| Seasonal allergy | Immune system disorders | — | — |
| Skin lesion | Skin and subcutaneous tissue disorders | — | — |
| Supplementation therapy | Surgical and medical procedures | — | — |
| Treponema test positive | Infections and infestations | — | — |
Most-reported serious reactions: low LDL.
Data from ClinicalTrials.gov NCT00367458 adverse events section.
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 drug's effectiveness.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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