NCT04249037

Brief Summary

This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2020

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

January 28, 2020

Last Update Submit

November 27, 2023

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Viral Suppression

    Proportion of participants with viral suppression to \<50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm.

    48 weeks

Study Arms (2)

Arm A: Rapid Start Group

ACTIVE COMPARATOR

Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.

Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)

Arm B: Standard Group

PLACEBO COMPARATOR

Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Drug: Standard initiation of antiretroviral therapy (ART)

Interventions

bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)DRUG

A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.

Also known as: Biktarvy
Arm A: Rapid Start Group
Standard initiation of antiretroviral therapy (ART)DRUG

Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Also known as: Standard of Care ART
Arm B: Standard Group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV.
  • Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours
  • Any primary language with access to an interpreter by phone is included.

You may not qualify if:

  • Pregnancy or intention to become pregnant in the next two years after enrollment
  • Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
  • Creatinine clearance \<30 mL/min by Cockcroft-Gault equation. (Therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance \<30 mL/min)
  • Prior history of known HIV diagnosis
  • Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis)
  • Allergy to bictegravir, emtricitabine or tenofovir alafenamide
  • Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of initiation of antiretroviral therapy (up to the discretion of the site PI)
  • Vulnerable populations including prisoners and individuals without decision making capacity
  • Concommitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

bictegraviremtricitabine tenofovir alafenamidebictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Hillary Dunlevy, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

December 15, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)