Evaluating a Triple Immune Regimen for Acute HIV-1
This study is looking at a new combination of treatments for adults who started antiretroviral therapy (ART) soon after being diagnosed with acute HIV-1. The goal is to see if these treatments can help control HIV-1 without needing daily ART. The study will test two vaccines, ChAdOx1.tHIVconsv1 and ChAdOx1.HIVconsv62, along with MVA.tHIVconsv3 and MVA.tHIVconsv4. It also includes a drug called Vesatolimod, which is given by mouth. Researchers want to know if these treatments are safe, how your body responds to them, and if they can help you maintain viral control during a period where you temporarily stop ART. You might be able to join if you are an adult, have been on ART for at least 12 months with no long interruptions, and started ART within 90 days of your acute HIV diagnosis. The study plans to enroll 36 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study with two arms, meaning some participants will receive the active treatments and others will receive a placebo, without knowing which they are getting. It plans to enroll 36 participants.
- What's involved
- Participants will go through several steps, including receiving study interventions and ART for 67 weeks, followed by an analytic treatment interruption (ATI) for up to 24 weeks. There are also optional steps for some participants.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor for serious side effects from Week 0 to Week 64, and assess viral control during the ATI from Week 0 to Week 16.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06071767
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
Suspended
PHASE1Ages 18+InterventionalTreatmentNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~36 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:ChAdOx1.tHIVconsv1ChAdOx1.HIVconsv62MVA.tHIVconsv3MVA.tHIVconsv4Vesatolimod (VES)GS-5423
At a glance
Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of any serious adverse event (AE), Grade 3 or higher AE, or AE that leads to permanent discontinuation of study treatment regardless of grade, that is related to ChAdOx1-MVA/HIVconsvX vaccines, vesatolimod, GS-5423 or GS-2872
Measured over Week 0 to Week 64
+1 more outcome measured
Conditions
Where it's being run
12 sites across 12 statesCalifornia1
Georgia1
Illinois1
Massachusetts1
Missouri1
New York1
North Carolina1
Ohio1
Study leadership
- Sharon Riddler, MD, MPH · STUDY_CHAIR · University of Pittsburgh
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Provision of written informed consent.
History of Initiation of combination ART within 90 days of acute HIV diagnosis
On ART for at least 12 months with no known ART interruption \>28 consecutive days within 12 months prior to Step 1 Study Entry
ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir/lamivudine regimen for at least 6 weeks prior to Study Entry.
Willingness to participate in the ATI and willingness to restart ART according to study guidelines.
Willingness to adhere to protocol therapy and complete all study visits.
Weight ≥50 kg and ≤150 kg at Screening.
CD4 cell count ≥450 cells/mm3 obtained within 60 days prior to Study Entry.
HIV-1 RNA \<50 copies/mL (or below the assay limit of quantification if local assay lower limit of quantification is \>50 copies/mL) for at least 1 year and within 60 days prior to Study Entry.
Select laboratory results within 60 days of study entry
For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry.
Participants who are able to become pregnant and who are engaging in sexual activity that could lead to pregnancy must agree to use two methods of contraception, one of which must be a highly effective methods for contraception. Barrier methods of contraception are required for the second method of contraception.
Availability of results of HLA typing (required for randomization).
Completion of pre-entry leukapheresis or LVBD.
Exclusion
Currently pregnant or breastfeeding or planning to become pregnant during study participation.
Prior receipt of anti-HIV broadly neutralizing antibody therapy.
Receipt of any non-HIV monoclonal antibody therapy within 1 year prior to study entry.
Prior receipt of a latency-reversing agent (LRA).
Receipt of HIV-1 or other investigational vaccines within 6 months prior to Study Entry.
Receipt of a live-virus vaccine within 60 days or any vaccination within 14 days prior to Study Entry.
Receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222) within 12 months prior to Step 1 Study Entry.
Known allergy/sensitivity or any hypersensitivity to components of study treatments or their formulations.
Known severe chicken egg allergy.
Known history of a severe reaction or anaphylaxis to prior vaccinations or antibody preparations (e.g., intravenous immunoglobulin).
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).
Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema.
Previous or current history of bleeding factor deficiency, coagulopathy or platelet disorder or on chronic anticoagulation.
History of inflammatory neurologic diseases.
History of pregnancy, head trauma or major surgery within 90 days prior to Step 1 Study Entry.
History of use of any immunomodulatory medications within the 6 months prior to Step 1 Study Entry.
Significant serious skin disease, such as but not limited to active rash, eczema, psoriasis, or urticaria.
Autoimmune disease (e.g., lupus, multiple sclerosis, and others) requiring ongoing immunosuppression.
Known history of CDC Stage 3 opportunistic infection (OI).
Any history of an HIV-associated malignancy.
Known or suspected active or untreated latent Mycobacterium tuberculosis infection.
Active or recent non-HIV-associated malignancy.
Serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry.
Known resistance to one or more drugs in two or more ARV drug classes.
History of or current clinical atherosclerotic cardiovascular disease
Current advanced liver disease.
Use of complementary or alternative medicines within 14 days prior study entry.
What this trial measures
- Occurrence of any serious adverse event (AE), Grade 3 or higher AE, or AE that leads to permanent discontinuation of study treatment regardless of grade, that is related to ChAdOx1-MVA/HIVconsvX vaccines, vesatolimod, GS-5423 or GS-2872Week 0 to Week 64
- Proportion of participants with viral control during an ATI defined as remaining off ART with HIV-1 RNA <1,000 copies/mL at Week 16 following ATI.Week 0 to Week 16 on Step 2