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Arm D: Lefitolimod/3BNC117 + 10-1074 for HIV (TITAN Trial)

Q: What criteria must be met in order to join this trial?

<p>This medical study seeks 47 individuals infected with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1, aged between 18 and 65. Furthermore, participants must have been on antiretroviral therapy for at least eighteen months and demonstrate sensitivity to the viral reservoir of 3BNC117 and 10-1074 prior to randomization.</p>

Phase 2

Waitlist Available

Led By Ole S Søgaard, MD PhD

Research Sponsored by University of Aarhus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 weeks.

Awards & highlights

TITAN Trial Summary

This trial will test if lefitolimod and 3BNC117/10-1074 are safe and effective in reducing the HIV-1 reservoir in people who are on ART and ATI.

Eligible Conditions

TITAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of ati (up to 26 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of ati (up to 26 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of ati (up to 26 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to re-initiation of cART during analytical treatment interruption (ATI)

Secondary outcome measures

Plasma HIV RNA doubling time

Safety and Tolerability assessment measured by AEs, Adverse Reactions (ARs), SAEs

TITAN Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Arm C: Placebo/3BNC117 + 10-1074Active Control2 Interventions

This arm will receive 3BNC117 + 10-1074 and placebo (sterile saline) for Lefitolimod.

Group II: Arm D: Lefitolimod/3BNC117 + 10-1074Active Control2 Interventions

This arm will receive both Lefitolimod and 3BNC117 + 10-1074.

Group III: Arm B: Lefitolimod/PlaceboActive Control2 Interventions

This arm will receive Lefitolimod and placebo (sterile saline) for 3BNC117 + 10-1074.

Group IV: Arm A: Placebo/PlaceboPlacebo Group1 Intervention

This arm will receive placebo (sterile saline) for both Lefitolimod and 3BNC117 + 10-1074.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aalborg University HospitalOTHER

367 Previous Clinical Trials

461,168 Total Patients Enrolled

University of UtahOTHER

1,099 Previous Clinical Trials

1,778,642 Total Patients Enrolled

Hvidovre University HospitalOTHER

426 Previous Clinical Trials

301,731 Total Patients Enrolled

Frequently Asked Questions

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

Has the combination of lefitolimod and 10-1074 been validated by the FDA?

"Arm D: Lefitolimod/3BNC117 + 10-1074 received a rating of 2 on our safety scale, as the trial is currently in Phase 2 and there is limited data supporting its efficacy."

Answered by AI

Have there been precedential clinical trials of the combination therapy involving Arm D: Lefitolimod/3BNC117 + 10-1074?

"Presently, there is 1 active clinical trial involving Arm D: Lefitolimod/3BNC117 + 10-1074 at Phase 3. Melbourne and Utah serve as the hotspots for these studies, though 8 different sites are running trials for this arm of research."

Answered by AI

Is there still an opportunity to join the investigation?

"Unfortunately, this clinical trial is no longer recruiting participants. Initially posted on May 6th 2019 and most recently updated on March 30th 2022, the study has since closed its doors to new patients. However, there are 853 studies actively enrolling those with human immunodeficiency virus type 1 (hiv-1) infection and one particular trial involving Lefitolimod/3BNC117 + 10-1074 that currently requires volunteers."

Answered by AI

Is enrollment open to participants younger than 85 years old?

"The enrollment guidelines for this trial stipulate that the minimum age of applicants is 18 and those over 65 are ineligible."

Answered by AI

What criteria must be met in order to join this trial?

"This medical study seeks 47 individuals infected with HIV-1, aged between 18 and 65. Furthermore, participants must have been on antiretroviral therapy for at least eighteen months and demonstrate sensitivity to the viral reservoir of 3BNC117 and 10-1074 prior to randomization."

Answered by AI

How many participants has this research endeavor recruited?

"This experiment is no longer recruiting participants, having last been updated on March 30th 2022. For those seeking other clinical trials for human immunodeficiency virus type 1 (hiv-1) infection, there are 853 studies available and one trial involving Lefitolimod/3BNC117 + 10-1074 currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV

2019. "Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03837756.