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HIV Capsid Inhibitor

Teropavimab for HIV

Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
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 day 1 up to week 52
Awards & highlights

Study Summary

This trial will study the safety of combining two HIV antibodies and a capsid inhibitor to see if they can tolerate the treatment.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
Secondary outcome measures
Change from Baseline in CD4+ Cell Count at Week 26
PK Parameter: AUClast of Teropavimab, and Zinlirvimab, and LEN
Structure of lenticular fasciculus
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Primary Cohorts: Lenacapavir (LEN), Teropavimab, Zinlirvimab Dose CExperimental Treatment4 Interventions
Participants will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + zinlirvimab Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + zinlirvimab Dose C.
Group II: Primary Cohorts: LEN, Teropavimab, Zinlirvimab Dose DExperimental Treatment4 Interventions
Participants will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + zinlirvimab Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + zinlirvimab Dose D.
Group III: Optional Cohorts: Lenacapavir (LEN), Teropavimab, Zinlirvimab Dose CExperimental Treatment4 Interventions
Optional cohort included participants from primary cohort who could not qualify for primary cohort at the study start. Participants in optional cohort will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + zinlirvimab Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + zinlirvimab Dose C.
Group IV: Optional Cohorts: LEN, Teropavimab, Zinlirvimab Dose DExperimental Treatment4 Interventions
Optional cohort included participants screened for primary cohort but could not qualify for primary cohort at the study start. Participants in optional cohort will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + zinlirvimab Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + zinlirvimab Dose D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zinlirvimab
2021
Completed Phase 1
~40
Teropavimab
2021
Completed Phase 1
~40
Oral Lenacapavir
2019
Completed Phase 2
~220
Subcutaneous Lenacapavir
2019
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,721 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,715 Total Patients Enrolled

Media Library

Lenacapavir (HIV Capsid Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04811040 — Phase 1
HIV Research Study Groups: Optional Cohorts: LEN, Teropavimab, Zinlirvimab Dose D, Primary Cohorts: LEN, Teropavimab, Zinlirvimab Dose D, Primary Cohorts: Lenacapavir (LEN), Teropavimab, Zinlirvimab Dose C, Optional Cohorts: Lenacapavir (LEN), Teropavimab, Zinlirvimab Dose C
HIV Clinical Trial 2023: Lenacapavir Highlights & Side Effects. Trial Name: NCT04811040 — Phase 1
Lenacapavir (HIV Capsid Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811040 — Phase 1

Frequently Asked Questions

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

Are there vacancies available for prospective participants in this trial?

"This investigation has since completed its recruitment period, with a posting date of April 8th 2021 and last update on November 4th 2022. Fortunately, there are still 1256 trials accepting participants suffering from infections while 5 studies have open enrollment to research GS-2872."

Answered by AI

How many geographic locations is this clinical experiment occurring in?

"There are a total of 23 locations recruiting for this medical trial, such as NC TraCS Institute-CTRC in Chapel Hill and Yale University School of Medicine's AIDS Program in New Haven. Additionally, Be Well Medical Center in Berkley is included among the other 20 sites."

Answered by AI

Has GS-2872 been granted regulatory authorization by the FDA?

"With limited data on both safety and efficacy, GS-2872 received a score of 1 when evaluated by our team at Power."

Answered by AI

What is the ceiling on participant numbers for this trial?

"This clinical trial is not accepting applicants at the moment. Initially posted on 8 April 2021, and recently updated on 4 November 2022, this study is inactive as of now. However, there are 1256 studies seeking participants with infections and 5 trials for GS-2872 that remain open to recruitment."

Answered by AI

Does this medical trial offer innovative approaches to treatment?

"GS-2872 has been a part of medical research since 2019, with the initial study sponsored by Gilead Sciences and involving 72 participants. Subsequent Phase 2 & 3 studies granted it drug approval which enabled its use in 5 presently active trials across 14 countries and 83 cities."

Answered by AI

Does the current research protocol allow for participants aged eighty or above?

"As set out in the prerequisites, individuals aged 18 to 65 can apply for this clinical trial."

Answered by AI

For whom is this trial open to participation?

"Those wishing to be part of this trial must have contracted a specific infection and abide by the age requirement (18-65). The total number of participants is projected at 32 individuals."

Answered by AI

Are there any other experiments that have been conducted using the GS-2872 compound?

"Presently, 5 clinical trials are researching GS-2872 with 3 of them in the final phase. The majority of these investigations are being conducted from San Juan and Michigan but there are over two hundred fifty three sites running studies related to this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
2021. "Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04811040.
~8 spots leftby Apr 2025
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