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Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD

NCT04311944 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-07-31

No results posted yet for this study

Summary

This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.

Conditions

Interventions

OTHER

Early fast-track care

Participants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is \<200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA \<200 copies will then be eligible for fast-track care, if they meet other eligibility criteria.

OTHER

Standard (deferred fast-track) care

Participants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is \<200 copies.mL, and they meet other eligibility criteria.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Florida International University

    collaborator OTHER

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    lead OTHER

Principal Investigators

  • Colette Guiteau, MD · Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

  • Serena Koenig, MD · Brigham and Women's Hospital/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-02-28
Completion
2022-05-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311944 on ClinicalTrials.gov