Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
ConditionHIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Cancer Institute (NCI)
About this trial
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 compare changes in the amount of virus in blood and lymph nodes after a short treatment interruption.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >=18 years.
People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies.
Established medical care outside NIH.
Able to provide informed consent.
Disqualifiers
Active intercurrent illness or infection, including fever >38 degrees Celsius.
Known history of initiating ART during the first year of infection with HIV. Participants will be considered to have initiated ART within 1 year of infection as defined by documented screening/confirmatory seroconversion (positive testing within one year of non-reactive HIV enzyme-linked immunosorbent assay).
Pregnant.
Breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Acute Treatment Interruption
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ATIExperimental treatment 1 intervention
Group B: Continue ARTNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Fold increase in HIV nucleic acids (RNA and DNA) in blood or lymphoid compartments from baseline to 10 day ATI vs baseline to no ATI.
Compare change in HIV DNA and RNA after 10 day ATI in peripheral circulation and lymphoid compartment.
Time frame
Up to day 90Secondary outcomes
1
6. Correlation of HIV RNA levels and cytokine and T-cell profiles.
Assess relationship between immune and inflammatory markers with viral load.
Time frame
Up to Month 62
5. HIV RNA and DNA sequence analyses for genetic studies and potential for replication.
Evaluate viral population characteristics including completeness of genome over the course of the study.
Time frame
Up to Month 63
4. Cytokine and T-cell profiles during suppression and after ATI criteria for treatment resumption are met.
Comparison of immune and inflammatory milieu at baseline and after re-suppression post ATI.
Time frame
Up to Month 64
3. Correlation between regional and overall change in 18F uptake with HIV DNA and RNA sequencing characteristics pre-ATI to post ATI.
Determine if the relationship between SUV and viral populations differs at baseline and follow up depending on ATI versus no ATI.
Time frame
Up to Month 6Sponsors and contacts
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Source ClinicalTrials.gov