Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
NCT ID: NCT06071767
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2024-04-01
2029-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
NCT06205056
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
NCT03205917
A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment
NCT03307915
Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART
NCT05604209
A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults
NCT02935686
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be screened for eligibility and have a pre-entry visit. After determination of eligibility, participants will be randomized prior to entry to either the active intervention arm (Arm A) or the placebo arm (Arm B) in a 2:1 ratio.
The study consists of four steps including an analytical treatment interruption (ATI).
* Step 1: Study Intervention and ART (67 weeks)
* Step 2: Analytic Treatment Interruption (up to 24 weeks)
* Step 3: ART Restart (24 weeks)
* Step 4: Continuation of ATI (up to 24 weeks)
Each participant will complete Step 1 and Step 2. At the end of Step 2, participants who have experienced virologic rebound will enter Step 3 and resume ART. Participants who did not meet ART restart criteria after 24 weeks in Step 2 will enter Step 4 for an extended ATI.
Each participant will be enrolled for up to approximately 110 weeks. The total time on study for each participant is dependent on the time spent in the treatment interruption steps (Step 2 and 4).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Active ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod and bnAbs
ChAdOx1.tHIVconsv1
Administered as 0.4 mL intramuscularly (IM) at Week 0
ChAdOx1.HIVconsv62
Administered as 0.3 mL IM at Week 0
MVA.tHIVconsv3
Administered as 0.3 mL IM at Week 4
MVA.tHIVconsv4
Administered as 0.5 mL IM at week 4
Vesatolimod (VES)
VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.
GS-5423
Administered via intravenous (IV) infusion at week 7
GS-2872
Administered via IV infusion at week 7
MVA.tHIVconsv4
Administered 0.5 mL IM at week 60
Arm B: Placebos for vaccines, vesatolimod and bnAbs
Placebo
Placebos for vaccines, VES, and bnAbs
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ChAdOx1.tHIVconsv1
Administered as 0.4 mL intramuscularly (IM) at Week 0
ChAdOx1.HIVconsv62
Administered as 0.3 mL IM at Week 0
MVA.tHIVconsv3
Administered as 0.3 mL IM at Week 4
MVA.tHIVconsv4
Administered as 0.5 mL IM at week 4
Vesatolimod (VES)
VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.
GS-5423
Administered via intravenous (IV) infusion at week 7
GS-2872
Administered via IV infusion at week 7
MVA.tHIVconsv4
Administered 0.5 mL IM at week 60
Placebo
Placebos for vaccines, VES, and bnAbs
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of Initiation of combination ART within 90 days of acute HIV diagnosis
* No known ART interruption \>14 consecutive days since initiation of ART.
* 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 ≥500 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) since initial viral suppression on ART and 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 Criteria
* 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 entry.
* Prior receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222).
* 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 study Entry.
* History of use of any immunomodulatory medications within the 6 months prior to 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Gilead Sciences
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sharon Riddler, MD, MPH
Role: STUDY_CHAIR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego AntiViral Research Center CRS
San Diego, California, United States
Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
Washington University Therapeutics CRS
St Louis, Missouri, United States
Columbia Physicians & Surgeons CRS
New York, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS
Greensboro, North Carolina, United States
Cincinnati CRS
Cincinnati, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12025
Identifier Type: OTHER
Identifier Source: secondary_id
HIV-CORE 009
Identifier Type: OTHER
Identifier Source: secondary_id
A5374
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.