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Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

NCT05630872 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-20

Study results available
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Summary

A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).

Conditions

  • HIV-associated Tuberculosis

Interventions

DRUG

Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC

Dolutegravir (DTG) 50 mg orally BID (\~12 hours apart) plus TDF/3TC, from study week 6 until 2 weeks after completion of TB treatment: Morning dose DTG 50 mg QD plus TDF/3TC from study-supplied ART regimen. Evening dose: DTG 50 mg orally QD from study-supplied source.

DRUG

DTG 50 mg orally QD plus TDF/3TC

DTG 50 mg orally QD plus TDF/3TC from two weeks after completion of TB treatment to end of study (week 48).

DRUG

2HPZM

Daily regimen of rifapentine 1200mg, moxifloxacin 400mg, isoniazid 300mg, and pyrazinamide at standard doses adjusted for body weight from study entry through study week 8.

DRUG

2HPM

Daily regimen of rifapentine 1200mg, moxifloxacin 400mg, and isoniazid 300mg from study week 8 through study week 17.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Mylan Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2025-05-07
Completion
2025-11-12
FDA Drug
Yes

Countries

  • South Africa
  • Thailand

Study Locations

More Related Trials

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 NCT05630872 on ClinicalTrials.gov