NCT06071767 · National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
What this study is about
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
View original scientific description
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Interventions
BIOLOGICAL
ChAdOx1.tHIVconsv1
Administered as 0.4 mL intramuscularly (IM) at Week 0
BIOLOGICAL
ChAdOx1.HIVconsv62
Administered as 0.3 mL IM at Week 0
BIOLOGICAL
MVA.tHIVconsv3
Administered as 0.3 mL IM at Week 4
BIOLOGICAL
MVA.tHIVconsv4
Administered as 0.5 mL IM at week 4
DRUG
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.
DRUG
GS-5423
Administered via intravenous (IV) infusion at week 7
DRUG
GS-2872
Administered via IV infusion at week 7
BIOLOGICAL
MVA.tHIVconsv4
Administered 0.5 mL IM at week 60
BIOLOGICAL
Placebo
Placebos for vaccines, VES, and bnAbs
Primary outcome 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-2872
Time frame: Week 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.
Time frame: Week 0 to Week 16 on Step 2
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of written informed consent.
- 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 rep
Where
- San Diego, California
- Atlanta, Georgia
- Chicago, Illinois
- Boston, Massachusetts
- St Louis, Missouri
- New York, New York
- Chapel Hill, North Carolina
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Houston, Texas
Collaborators
University of Oxford, Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations