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Integrase Inhibitor

Arm 1: DTG + INH + RPT for Latent Tuberculosis Infection

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 measured at days 28 and 42
Awards & highlights

Study Summary

This trial will study the potential for drug interactions when taking dolutegravir with rifapentine and isoniazid to treat latent tuberculosis infection in people also infected with HIV.

Eligible Conditions
  • Latent Tuberculosis Infection
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at days 28 and 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at days 28 and 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DTG PK Parameter Area Under the Curve (AUC0-12 for BID & AUC0-24 for QD dosing) by visit week and arm
DTG PK Parameter Maximum Plasma Concentration (Cmax) by visit week and arm
DTG PK Parameter Minimum Plasma Concentration (Cmin) by visit week and arm
Secondary outcome measures
Upper arm
Proportion of participants with HIV-1 RNA levels >50 copies/mL
Proportion of participants with all adverse events meeting the reporting criteria in the study protocol during administration of DTG with 1HP, by arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: DTG + INH + RPTExperimental Treatment5 Interventions
Participants will receive 50 mg of DTG orally each morning. Participants will receive 300 mg of INH and 600 mg of RPT orally each morning for 4 weeks. Participants will also receive 25 or 50 mg of pyridoxine (vitamin B6) with each dose of INH. Participants will remain on once-daily DTG-based ARV treatment with 2 NRTIs (excluding TAF) during the study. DTG will be from non-study ARV supply. NOTE: Arm 2 will only open based on assessment of DTG pharmacokinetics (PK) data from participants in Arm 1.
Group II: Arm 1: DTG + INH + RPTExperimental Treatment5 Interventions
Participants will receive 50 mg of DTG orally twice daily (~12 hours apart). Participants will receive 300 mg of INH and 600 mg of RPT orally each morning for 4 weeks. Participants will also receive 25 or 50 mg of pyridoxine (vitamin B6) with each dose of INH. Participants will remain on DTG-based ARV treatment with 2 NRTIs (excluding TAF) during the study. Participants will take non-study supply of DTG for morning doses, and will take study-supplied DTG for evening doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dolutegravir (DTG)
2016
Completed Phase 4
~1640
Rifapentine (RPT)
2012
Completed Phase 3
~3110
Pyridoxine (Vitamin B6)
2012
Completed Phase 3
~3000
Isoniazid (INH)
2016
Completed Phase 4
~4110
Antiretroviral Therapy (ART)
2002
N/A
~5480

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,628 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
359 Previous Clinical Trials
468,471 Total Patients Enrolled
Anthony Podany, PharmDStudy ChairUniversity of Nebraska

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ucsf Hiv/Aids Crs
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals
2020. "Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04272242.
~13 spots leftby Feb 2025
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