Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated … (NCT06071767) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
United States, Brazil36 participantsStarted 2024-04-01
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves stopping ART temporarily during something called an analytical treatment interruption — what does that mean for my personal health risks, and how would my care team monitor me if my viral load starts climbing during that period?
2The study is testing a combination of two vaccines plus two other investigational drugs — since this is still a Phase 1/2 trial, what is actually known so far about whether this combination is safe, and what side effects should I realistically be prepared for?
3One of the main things being measured is whether participants can keep their HIV viral load below 1,000 copies per milliliter for 16 weeks without ART — given where my own health stands right now, does my doctor think that goal is realistic or risky for me specifically?
4Since I was recently diagnosed and this trial requires starting ART during acute HIV infection, does the timing of when I was diagnosed affect whether this trial might even be worth discussing as an option with my care team?
5If I were to experience a serious adverse event related to one of the vaccines or the other study drugs, what would happen — would I go back on ART immediately, and how would that affect my overall treatment plan going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Week 0 to Week 64
2
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.
Timeframe: Week 0 to Week 16 on Step 2
Trial details
NCT IDNCT06071767
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)