What side effects are associated with this type of intervention?

Antiretroviral therapy (ART), the standard treatment for HIV/AIDS, commonly causes side effects such as gastrointestinal issues (nausea, diarrhea), fatigue, headache, and dizziness. Long-term use may lead to liver toxicity, kidney damage, cardiovascular issues, and metabolic changes like lipodystrophy and insulin resistance. ART can also interact with other medications, requiring careful management of drug-drug interactions.

What prior FDA approvals exist?

The FDA has approved several classes of antiretroviral drugs for the treatment of HIV/AIDS, including nucleoside reverse transcriptase inhibitors (NRTIs) like zidovudine and lamivudine, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz and rilpivirine, protease inhibitors (PIs) like ritonavir and lopinavir, integrase strand transfer inhibitors (INSTIs) such as raltegravir and dolutegravir, and entry inhibitors like maraviroc. These drugs are used in combination to form highly active antiretroviral therapy (HAART), which effectively reduces viral load and improves immune function. The PET/CT scan with tracer study aims to visualize HIV-infected cells, complementing the role of ART in managing and monitoring the infection.

What other types of research exist?

Promising novel alternatives to PET/CT scans with tracers for visualizing HIV-infected cells in HIV/AIDS patients include: 1) MRI with advanced contrast agents, which can provide high-resolution images without radiation exposure; 2) Single Photon Emission Computed Tomography (SPECT) with novel radiotracers, offering improved specificity for detecting HIV-infected cells; and 3) Optical imaging techniques, such as fluorescence and bioluminescence imaging, which are less invasive and can provide real-time visualization of cellular processes.

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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

Must not have

Participants with history of HIV-associated dementia or progressive multifocal leukoencephalopathy

Participants with hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special scans and tissue samples to find and study areas in the body where HIV might still be active in adults receiving ongoing HIV treatment.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV-related brain issues.

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I have liver problems.

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I have an active hepatitis C infection.

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I currently have an opportunistic infection.

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I have not had an AIDS-defining illness in the last 3 years.

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I am currently on long-term steroid medication.

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I cannot have IV contrast due to health reasons.

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I have HIV drug resistance.

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I do not have any ongoing illnesses or infections, including a fever over 38°C.

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I have an active or chronic hepatitis B infection.

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I have a history of heart problems or am at high risk for them.

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My current treatment is not compatible with treatment interruptions.

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I have kidney problems.

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I have a history of diabetes that is hard to control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which includes several classes of drugs targeting different stages of the HIV life cycle. Nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) block the reverse transcriptase enzyme, protease inhibitors (PIs) inhibit the protease enzyme, integrase strand transfer inhibitors (INSTIs) prevent viral DNA from integrating into the host genome, and entry inhibitors block the virus from entering host cells. These treatments are essential for controlling HIV infection and preventing disease progression. The PET/CT Scan with Tracer study aims to visualize HIV-infected cells, which is crucial for understanding the persistence of HIV in the body despite ART, potentially leading to more targeted treatments and strategies to eradicate the virus.

Defining Study Outcomes That Better Reflect Individual Response to Treatment.Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults.The case for more cautious, patient-focused antiretroviral therapy.