Trial · NCT02833844
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
NCT02833844, Phase 3, Completed, Amgen; results first posted 2020-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia. Trials, record NCT02833844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02833844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
- NCT number
- NCT02833844
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 467 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
- Interventions
- Evolocumab, Placebo
- First posted
- 2016-07-14
- Last updated
- 2022-07-22
- Other registries' IDs
- eudract:2015-004735-12
- Results first posted
- 2020-07-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Change From Baseline in LDL-C at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Week 24 | |
| Secondary | Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Baseline, Week 24 | |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percent Change From Baseline in Triglycerides at Week 24 | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
| Secondary | Percent Change From Baseline in HDL-C at Week 24 | Bseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in LDL-C at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with observed data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with observed data. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides at Week 24 | Baseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in HDL-C at Week 24 | Bseline, Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in LDL-C at Week 24 | Double-Blind Placebo | 1.68 | Standard Error 2.03 | percent change | |
| Percent Change From Baseline in LDL-C at Week 24 | Double-Blind Evolocumab | -55.23 | Standard Error 1.52 | percent change | |
| Change From Baseline in LDL-C at Week 24 | Double-Blind Placebo | -2.3 | Standard Error 3.1 | mg/dL | |
| Change From Baseline in LDL-C at Week 24 | Double-Blind Evolocumab | -77.5 | Standard Error 2.3 | mg/dL | |
| Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Double-Blind Placebo | 7.9 | 95% Confidence Interval 4.6 to 13.4 | percentage of participants | |
| Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Double-Blind Evolocumab | 73.3 | 95% Confidence Interval 68.0 to 78.0 | percentage of participants | |
| Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Double-Blind Placebo | 0.7 | 95% Confidence Interval 0.1 to 3.7 | percentage of participants | |
| Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Double-Blind Evolocumab | 72.5 | 95% Confidence Interval 67.2 to 77.3 | percentage of participants | |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Double-Blind Placebo | 2.86 | Standard Error 1.74 | percent change | |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Double-Blind Evolocumab | -48.07 | Standard Error 1.31 | percent change |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | Double-Blind Placebo/Open-Label Evolocumab | 157 | |
| Double-Blind Period | STARTED | Double-Blind Evolocumab/Open-Label Evolocumab | 310 | |
| Double-Blind Period | Randomized and Treated | Double-Blind Placebo/Open-Label Evolocumab | 157 | |
| Double-Blind Period | Randomized and Treated | Double-Blind Evolocumab/Open-Label Evolocumab | 307 | |
| Double-Blind Period | COMPLETED | Double-Blind Placebo/Open-Label Evolocumab | 155 | |
| Double-Blind Period | COMPLETED | Double-Blind Evolocumab/Open-Label Evolocumab | 303 | |
| Double-Blind Period | NOT COMPLETED | Double-Blind Placebo/Open-Label Evolocumab | 2 | |
| Double-Blind Period | NOT COMPLETED | Double-Blind Evolocumab/Open-Label Evolocumab | 7 | |
| Open-Label Period | STARTED | Double-Blind Placebo/Open-Label Evolocumab | 152 | |
| Open-Label Period | STARTED | Double-Blind Evolocumab/Open-Label Evolocumab | 303 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events268
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Placebo | 4 | 157 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Evolocumab | 3 | 307 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Placebo/Open-Label Evolocumab | 0 | 152 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Evolocumab/Open-Label Evolocumab | 0 | 299 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind Placebo | 7 | 157 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind Evolocumab | 11 | 307 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind Placebo/Open-Label Evolocumab | 1 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind Evolocumab/Open-Label Evolocumab | 8 | 299 | |
| other | Chest pain | General disorders | Double-Blind Placebo | 5 | 157 | |
| other | Chest pain | General disorders | Double-Blind Evolocumab | 2 | 307 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Placebo | 0 | 157 |
| Total, all-cause mortality | Double-Blind Evolocumab | 0 | 310 |
| Total, all-cause mortality | Double-Blind Placebo/Open-Label Evolocumab | 0 | 152 |
| Total, all-cause mortality | Double-Blind Evolocumab/Open-Label Evolocumab | 2 | 303 |
| Total, other adverse events | Double-Blind Placebo | 41 | 157 |
| Total, other adverse events | Double-Blind Evolocumab | 78 | 307 |
| Total, other adverse events | Double-Blind Placebo/Open-Label Evolocumab | 23 | 152 |
| Total, other adverse events | Double-Blind Evolocumab/Open-Label Evolocumab | 50 | 299 |
| Total, serious adverse events | Double-Blind Placebo | 8 | 157 |
| Total, serious adverse events | Double-Blind Evolocumab | 10 | 307 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02833844
GET https://conductscience.org/api/trials/v1/NCT02833844/results?page=2