NCT03731559

Brief Summary

The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV/TB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_2

Geographic Reach
1 country

10 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

6 years

First QC Date

October 31, 2018

Last Update Submit

September 30, 2024

Conditions

HIV/TB Coinfection

Keywords

EfficacysafetypharmacokineticsDolutegravirHIV/TB co-infected patientsrifampin-based antituberculosis therapy

Outcome Measures

Primary Outcomes (1)

  • proportion of subjects from the ITT analysis population with plasma HIV-1 RNA <50 c/mL at Week 24

    The primary efficacy endpoint is the proportion of subjects from the ITT analysis population with plasma HIV-1 RNA \<50 c/mL at Week 24.

    Week 24

Secondary Outcomes (23)

  • AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

    Week 4

  • Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

    Week 4

  • Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

    Week 4

  • Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID

    Week 4

  • Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24

    Week 24

  • +18 more secondary outcomes

Study Arms (2)

DTG 50 mg OD with food

ACTIVE COMPARATOR

DTG 50 mg OD with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

Drug: DTG 50 mg OD with food

DTG 50 mg BID

ACTIVE COMPARATOR

DTG 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

Drug: DTG 50 mg BID

Interventions

DTG 50 mg OD with foodDRUG

Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy

DTG 50 mg OD with food
DTG 50 mg BIDDRUG

Dolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.

DTG 50 mg BID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented HIV positive
  • Aged \>18 years
  • ARV naïve (previous exposure to ARV for \< 2 weeks)
  • Any CD4 cell count
  • ALT \<5 times ULN
  • estimated GFR\>60 ml/min/1.73m2
  • Hemoglobin \>7 mg/L
  • TB is diagnosed and there is a plan to receive stable doses of RIF containing anti-TB therapy for at least another 4 week period after initiation of ART
  • No other active OI (CDC class C event) except oral candidiasis or disseminated MAC
  • Body weight \>40kg
  • Able to provide written informed consent

You may not qualify if:

  • Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs
  • Have previously treated for tuberculosis
  • Currently using immunosuppressive agents.
  • Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine
  • Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator
  • Unlikely to be able to remain in the follow-up period as defined by the protocol
  • Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
  • Have Karnofsky performance score \<30%
  • Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug)
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Klang Hospital

Bangkok, Bangkok, 10100, Thailand

RECRUITING

Bhumibol Adulyadej Hospital

Bangkok, Bangkok, 10220, Thailand

RECRUITING

Infectious Disease, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Infectious Disease Taksin Hospital

Bangkok, Bangkok, 10600, Thailand

RECRUITING

Infectious Disease Chonburi Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

RECRUITING

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

RECRUITING

Infectious Disease Buddhachinaraj Phitsanulok Hospital

Phitsanulok, Changwat Phitsanulok, 65000, Thailand

RECRUITING

Infectious Disease Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, 57000, Thailand

RECRUITING

Chest Division, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

HIV-NAT, Thai Red Cross - AIDS Research Centre

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

dolutegravirFoodBID protein, human

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Anchalee Avihingsanon, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

June Ohata, BS

CONTACT

6626523040juneohata4@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 6, 2018

Study Start

June 25, 2019

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

TH(10)