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Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals

NCT03225118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2020-01-18

No results posted yet for this 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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael C Sneller, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2020-01-16
Completion
2020-01-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03225118 on ClinicalTrials.gov