Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals
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|ClinicalTrials.gov Identifier: NCT03225118|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 15, 2018
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.
To study the impact of a short-term treatment stop on HIV that persists even while taking cART.
Adults 18-65 years old with HIV who are being treated with cART
- 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Comprehensive Evaluation of the Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals|
|Actual Study Start Date :||July 17, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||January 1, 2025|
HIV-infected Adults (age 18-65 years) on ART with suppressed viremia willing to interrupt treatment and then restart once criteria is met.
- The time to plasma viral rebound in HIV-infected individuals undergoing analytical treatment interruption. [ Time Frame: The outcome will be satisfied when each subject meets restart criteria. ]
- The difference in frequency of HIV infected CD4+ and CD8+ T cells and the respective expression of immune exhaustion markers prior to and following ATI and after re-initiation of ART. [ Time Frame: The time points to evaluate the outcome differences will be at baseline, during treatment interruption and after cART is restarted. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225118
|Contact: Catherine A Seamon, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Michael C Sneller, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|