ATI for Human Immunodeficiency Virus (HIV) Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Human Immunodeficiency Virus (HIV) Infections
Acute Treatment Interruption - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Background: Human immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection. ART stops HIV from infecting cells, but HIV does not go away. Some infected cells remain. If ART is stopped, then HIV levels will rise and infect more cells. Objective: To find where HIV-infected cells are located in the body, even when ART is keeping levels low. Eligibility: Adults aged 18 years or older who are undergoing ART for HIV infection. Design: Participants will be screened with a physical exam, including blood tests. They will be assigned to 1 of 2 groups: One group will stay on ART. They will have 2 study visits: the first 45 days after screening, and the second 12 to 16 weeks later. They will have a PET/CT scan at each visit. A substance called a tracer will be injected into their arm. They will lie still on a table that moves through a doughnut-shaped machine. This process takes up to 2 hours. The other group will stop ART for no more than 90 days. This group will have 3 PET/CT scans over 8 months. Once they stop ART, they will visit the clinic weekly for blood tests. After restarting ART, they will continue to visit the clinic weekly until their HIV level is safe. All participants will have small samples of tissue taken from lymph nodes. They may also opt to provide semen samples or vaginal fluid. They may have samples taken of bone marrow or the fluid inside their spinal column....

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to Month 6

Up to Month 6
1. Levels of HIV DNA and integration site analysis to assess clonal distribution at different biopsy sites, semen, vaginal swabs, and PBMCs.
1.Levels of HIV DNA and integration site analysis to assess clonal distribution at different biopsy sites, semen, vaginal swabs, and PBMCs.
2. Correlation between regional and overall change in PET SUV with HIV DNA and RNA sequencing characteristics pre-ATI to post ATI
2.Correlation between regional and overall change in PET SUV (see section 9.3) with HIV DNA and RNA sequencing characteristics pre-ATI to post ATI
3. Cytokine and T-cell profiles during suppression and after ATI criteria for treatment resumption are met.
3.Cytokine and T-cell profiles during suppression and after ATI criteria for treatment resumption are met.
4. HIV RNA and DNA sequence analyses for genetic studies and potential for replication competence.
4.HIV RNA and DNA sequence analyses for genetic studies and potential for replication competence.
5. Correlation of HIV RNA levels and cytokine and T-cell profiles
5.Correlation of HIV RNA levels and cytokine and T-cell profiles
Correlation between regional and overall change in PET SUV with HIV DNA and RNA sequencing characteristics pre-ATI to post ATI
Correlation of HIV RNA levels and cytokine and T-cell profiles
Cytokine and T-cell profiles during suppression and after ATI criteria for treatment resumption are met.
HIV RNA and DNA sequence analyses for genetic studies and potential for replication competence.
Levels of HIV DNA and integration site analysis to assess clonal distribution at different biopsy sites, semen, vaginal swabs, and PBMCs.
Up to day 90
Proportion of participants who have a 3 fold increase in HIV RNA levels in tissue sites identified by imaging as having increased SUV on FDG-PET as defined below

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Continue ART
1 of 2
ATI
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: ATI · No Placebo Group · Phase 2

ATI
Other
Experimental Group · 1 Intervention: Acute Treatment Interruption · Intervention Types: Other
Continue ARTNoIntervention Group · 1 Intervention: Continue ART · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 6
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
30 TrialsResearching Human Immunodeficiency Virus (HIV) Infections
270 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have HIV infection and have had a viral load of <40 copies/mL for at least 3 years
You have a CD4 cell count of at least 350 cells/microliter.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.