A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)

Summary

The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.

Conditions

• Tuberculosis

Interventions

DRUG

Isoniazid

Administered orally once daily

DRUG

Rifampin

Administered orally once daily

DRUG

Pyrazinamide

Administered orally once daily

DRUG

Ethambutol

Administered orally once daily

DRUG

Rifapentine

Administered orally once daily

DRUG

Moxifloxacin

Administered orally once daily

Sponsors & Collaborators

• ViiV Healthcare

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Gustavo Velásquez, MD, MPH · University of California, San Francisco

• Patrick Phillips, PhD · San Francisco General Hospital

• Susan Dorman, MD · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-05

Primary Completion

2029-06-05

Completion

2029-10-22

FDA Drug

Yes

Countries

• Argentina
• Australia
• Botswana
• Brazil
• Haiti
• India
• Kenya
• Malawi
• Mexico
• Peru
• Philippines
• Tanzania
• Thailand
• Uganda
• Vietnam
• Zimbabwe

Study Locations