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Virus Therapy

Triple Immune Regimen for HIV

Q: Are individuals currently able to enroll in this investigation?

<p>Data on clinicaltrials.gov show that this trial, which was posted in October of 2023 and most recently updated in October as well, is not presently enrolling patients. However, 94 other medical research projects are currently accepting participants.</p>

Q: In how many healthcare facilities is this clinical trial being conducted?

<p>This research is recruiting patients from Ponce de Leon Center CRS in Atlanta, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> General Hospital CRS (MGH CRS) in Boston and Northwestern University CRS in Chicago. Additionally, there are 12 other sites offering enrollment opportunities.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 on step 1 to 12 months following the last dose of study vaccination

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 on step 1 to 12 months following the last dose of study vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 on step 1 to 12 months following the last dose of study vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 on step 1 to 12 months following the last dose of study vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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, VES, GS-5423 or GS-2872

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.

Secondary outcome measures

Change in HIV-specific CD8+ T-cell-mediated viral inhibition as measured by in vitro virus inhibition assay (VIA) using representative viruses from major HIV-1 clades of group M.

Change in cell-associated HIV-1 RNA and DNA levels

Change in intact proviral DNA levels (IPDA)

+10 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,217 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,192 Total Patients Enrolled

University of OxfordOTHER

1,055 Previous Clinical Trials

16,202,479 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to enroll in this investigation?

"Data on clinicaltrials.gov show that this trial, which was posted in October of 2023 and most recently updated in October as well, is not presently enrolling patients. However, 94 other medical research projects are currently accepting participants."

Answered by AI

In how many healthcare facilities is this clinical trial being conducted?

"This research is recruiting patients from Ponce de Leon Center CRS in Atlanta, Massachusetts General Hospital CRS (MGH CRS) in Boston and Northwestern University CRS in Chicago. Additionally, there are 12 other sites offering enrollment opportunities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

2024. "Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071767.