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NCT03225118 · ClinicalTrials.gov registry record
Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals
A clinical trial of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 29
- Enrollment target
- 1
- Study location
NCT03225118: Completed study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03225118 is a study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 29 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225118, a study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some people develop resistance to the drugs or have permanent side effects. Objective: To study the impact of a short-term treatment stop on HIV that persists even while taking cART. Eligibility: Adults 18-65 years old with HIV who are being treated with cART Design: * Participants will first be screened with a physical exam and medical history. They may have a chest x-ray. They will have heart, blood, and urine tests. * At the baseline visit, participants will repeat the screening tests except the x-ray. They will get counseling about HIV and risk behavior. * Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will separate white blood cells from the rest of the blood. The remainder of the blood will be returned to the body by a different needle. * Participants will stop their current treatment on day 0. They will visit the clinic each week until they meet the criteria to restart cART. These visits will have the same procedures as the baseline visit. * Before restarting cART, most participants will have leukapheresis. * After restart, participants will be seen weekly for 4 weeks and then monthly for about 11 months. Participants will have blood drawn, physical exam, and medical history. They will have leukapheresis 2 more times over 1 year.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2020-01-16 |
What the finished NCT03225118 record still lists
NCT03225118 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 0 interventions.
NCT03225118 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03225118 about?
NCT03225118 is a clinical study titled "Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals". Background: The immune system helps the body fight off disease. Most people infected with HIV cannot control the infection and need daily medicine. Combination antiretroviral therapy (cART) are drugs taken to prevent HIV infection from damaging the immune system. Researchers want to study why some ...
What is the current status of trial NCT03225118?
This trial is currently completed. The enrollment target is 29 participants. The study started on 2017-07-17. Estimated completion is 2020-01-16.
What conditions does trial NCT03225118 study?
This clinical trial studies the following conditions: HIV.
Who is sponsoring clinical trial NCT03225118?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03225118 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03225118's enrollment target sits among peer trials
29 274th of 303 higher than 30 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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.
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