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NCT02652546 · ClinicalTrials.gov registry record · Phase 1
CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT02652546: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02652546 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02652546, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Background: When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick after they start HIV drugs because their recovering immune systems cause too much inflammation. Or their immune systems can become activated all the time. This can cause serious health problems. Researchers want to test if the drug CC-11050 helps treat inflammation in people taking HIV drugs. Objectives: To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs. To see if it reduces inflammation. Eligibility: People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1 year. Design: Participants will be screened with: Medicine review Physical exam and medical history Blood and urine tests Chest x-ray Electrocardiogram (ECG): Soft electrodes on the skin record heart signals. Participants will be randomly assigned to take capsules of either CC-11050 or a placebo. They will take the capsules every day for 12 weeks. They will continue to take their HIV drugs. Participants will have a baseline visit within 2 months of screening. This includes: Physical exam and medical history Blood and urine tests ECG Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm. Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit. These may include repeats of some of the baseline tests.
Interventions
- DRUG Assess Safety
- DRUG Effect of drug on viral load
- DRUG Effect of drug on T-cell count
- DRUG Effect of drug on inflammatory biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-01-09 |
| Est. Completion | 2018-11-02 |
| Phase | Phase 1 |
What the finished NCT02652546 record still lists
NCT02652546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 4 interventions - of which Assess Safety is the first listed.
NCT02652546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02652546 about?
NCT02652546 is a clinical study titled "CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)". Background: When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick after they start HIV drugs because their recovering immune systems cause too much inflammation. Or their immun...
What is the current status of trial NCT02652546?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2016-01-09. Estimated completion is 2018-11-02.
What interventions are being tested in trial NCT02652546?
The interventions under investigation include: Assess Safety (DRUG), Effect of drug on viral load (DRUG), Effect of drug on T-cell count (DRUG), Effect of drug on inflammatory biomarkers (DRUG).
Who is sponsoring clinical trial NCT02652546?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02652546's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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