Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
Public ClinicalTrials.gov record NCT02833844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM. The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
Study identification
- NCT ID
- NCT02833844
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 467 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2017 (Actual)
- Primary completion
- Jul 9, 2019 (Actual)
- Completion
- Jan 27, 2020 (Actual)
- Last update posted
- Jul 22, 2022
2017 – 2020
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | 90035 | — |
| Research Site | Hartford | Connecticut | 06102 | — |
| Research Site | Washington D.C. | District of Columbia | 20005 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Washington D.C. | District of Columbia | 20037 | — |
| Research Site | Miami | Florida | 33136 | — |
| Research Site | Tampa | Florida | 33602 | — |
| Research Site | Vero Beach | Florida | 32960 | — |
| Research Site | Augusta | Georgia | 30912 | — |
| Research Site | Berkley | Michigan | 48072 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Southfield | Michigan | 48075 | — |
| Research Site | Minneapolis | Minnesota | 55415 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Camden | New Jersey | 08103 | — |
| Research Site | Albany | New York | 12208 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | The Bronx | New York | 10467 | — |
| Research Site | Cincinnati | Ohio | 45267 | — |
| Research Site | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02833844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2022 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02833844 live on ClinicalTrials.gov.