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Imaging and Biopsy During Treatment Interruption for HIV/AIDS
Phase 2
Recruiting
Led By Chuen-Yen C Lau, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be willing to allow genetic testing
Participants must be aged 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights
Study Summary
This trial is testing if PET/CT scans can show where HIV-infected cells are in people's bodies, even when ART is keeping the virus levels low.
Who is the study for?
Adults over 18 with HIV, on ART for at least 3 years with low viral levels, and a CD4 count of >=350 cells/microliter. They must consent to genetic testing and allow future research use of their samples. Participants agree to stop ART for up to 90 days and use barrier contraception or abstain from sex until viral re-suppression post-ART.Check my eligibility
What is being tested?
The study is examining the location of HIV-infected cells in individuals on ART by comparing two groups: one continues ART while undergoing PET/CT scans; the other stops ART temporarily for additional scans and frequent blood tests before resuming treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort from biopsy procedures, risks associated with PET/CT imaging such as exposure to radiation, reactions to tracer injections or contrast used during scans, and increased HIV levels when interrupting ART.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to undergo genetic testing.
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I am 18 years old or older.
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I am willing to pause my ART treatment for up to 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
1.Levels of HIV DNA and integration site analysis to assess clonal distribution at different biopsy sites, semen, vaginal swabs, and PBMCs.
Positron-Emission Tomography
3.Cytokine and T-cell profiles during suppression and after ATI criteria for treatment resumption are met.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ATIExperimental Treatment1 Intervention
Participants randomized to ATI will halt their ART medications starting 2 weeks (more or less 3 days) after the first imaging visit. This plan will be discussed with participants during the baseline visit. Patients will be contacted 1-3 days prior to ATI initiation. ATI may be delayed or cancelled if there are new safety concerns. HIV plasma viral levels and CD4 counts will be monitored every week during the ATI phase. If a participant meets any of the ART restart criteria during the ATI phase, then they will discontinue ATI and restart ART. Participants who do not meet restart criteria will remain off ART and continue to be monitored weekly until they have been on ATI for 90 days, and then will restart ART.
Group II: Continue ARTActive Control1 Intervention
Participants will continue on their pre-study ART throughout the trial.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,222 Total Patients Enrolled
Chuen-Yen C Lau, M.D.Principal InvestigatorNational Cancer Institute (NCI)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of HIV-related brain issues.I have liver problems.I have an active hepatitis C infection.I have a health condition that could make stopping my current treatment risky.I currently have an opportunistic infection.I have not had an AIDS-defining illness in the last 3 years.I am currently on long-term steroid medication.I cannot have IV contrast due to health reasons.I have HIV drug resistance.I do not have any ongoing illnesses or infections, including a fever over 38°C.I have an active or chronic hepatitis B infection.I am willing to undergo genetic testing.My viral load has been under 40 copies/mL for 3 years, with occasional increases under 200 copies/mL.I am on an approved HIV treatment regimen.I have a history of heart problems or am at high risk for them.My current treatment is not compatible with treatment interruptions.I am 18 years old or older.I have kidney problems.I am willing to pause my ART treatment for up to 90 days.I have a history of diabetes that is hard to control.I am not on medication that affects FDG distribution.
Research Study Groups:
This trial has the following groups:- Group 1: ATI
- Group 2: Continue ART
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in this experiment?
"Affirmative. Information available on clinicaltrials.gov specifies that this research project, originally posted on December 7th 2022, is actively seeking individuals to join the study. With one site currently recruiting, 50 participants are needed in total."
Answered by AI
Are there any remaining vacancies for participation in this clinical experiment?
"As clinicaltrials.gov highlights, this clinical trial is actively recruiting participants; the study was initially uploaded on December 7th 2022 and its most recent edition occurred on December 1st 2022."
Answered by AI
Has the FDA granted authorization to Acute Treatment Interruption?
"We have evaluated Acute Treatment Interruption's safety in comparison to existing clinical data and judged it a 2, as there is evidence of its safety but none regarding efficacy."
Answered by AI
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