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Virus Therapy

Triple Immune Regimen for HIV

Phase 1 & 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry
Completion of pre-entry leukapheresis or LVBD
Must not have
History of inflammatory neurologic diseases
Prior receipt of a latency-reversing agent (LRA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will test if a vaccine, antibodies and a drug can help control HIV-1 without needing antiretroviral drugs.

Who is the study for?
Adults who started ART for acute HIV within 28 days of diagnosis, have been on consistent treatment without breaks longer than 14 days, and have maintained an undetectable viral load for at least a year. They must weigh between 50-115 kg, have a CD4 count ≥500 cells/mm3, and agree to use two forms of contraception if applicable.
What is being tested?
The trial is testing the effectiveness of therapeutic vaccines using ChAdV and MVA vectors along with TLR7 agonist vesatolimod (VES) and bNAbs versus placebo in controlling HIV during treatment interruption. Participants will be monitored to see how well their bodies control HIV without regular medication.
What are the potential side effects?
Potential side effects include typical vaccine reactions like soreness at injection site or fever, as well as possible immune responses such as fatigue or flu-like symptoms. The TLR7 agonist may cause gastrointestinal issues or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have taken a pregnancy test within the last 48 hours and it was negative.
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I have completed a leukapheresis or LVBD procedure.
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I have been on HIV treatment with specific drugs for at least 6 weeks.
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My weight is between 50 kg and 115 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had inflammatory diseases affecting my nervous system.
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I have previously received treatment with a latency-reversing agent.
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I have a history of bleeding disorders or I'm on long-term blood thinners.
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I do not have serious skin conditions like severe rashes or eczema.
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I have had a serious infection due to a weak immune system.
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I have or recently had cancer that is not related to HIV.
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I have a history of heart disease related to artery blockage.
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My liver disease is in an advanced stage.
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I have received a simian adenovirus-vectored vaccine before.
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I have severe allergies or reactions to certain medications.
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I haven't been hospitalized or needed serious treatment in the last 3 months.
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I have received monoclonal antibody therapy, not for COVID.
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I have had cancer linked to HIV.
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I have HIV that is resistant to drugs in at least two classes.
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I have or might have an active or untreated TB infection.
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I have an autoimmune disease and am on continuous immunosuppressants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Active ChAdV and MVA vaccines, vesatolimod and bnAbsExperimental Treatment7 Interventions
Group II: Arm B: Placebos for vaccines, vesatolimod and bnAbsPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVA.tHIVconsv3
2019
Completed Phase 1
~30
MVA.tHIVconsv4
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,854 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,719 Total Patients Enrolled
University of OxfordOTHER
1,097 Previous Clinical Trials
16,695,810 Total Patients Enrolled
Sharon Riddler, MD, MPHStudy ChairUniversity of Pittsburgh
1 Previous Clinical Trials
40 Total Patients Enrolled
~28 spots leftby Apr 2026
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