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Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?

NCT ID NCT03731559

Disease control Sponsor: The HIV Netherlands Australia Thailand Research Collaboration Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing two ways to give the HIV drug dolutegravir to people who also have tuberculosis and are taking rifampin-based TB therapy. Rifampin can lower dolutegravir levels in the body, so the trial compares taking 50 mg once daily with food against taking 50 mg twice daily. The goal is to see which approach keeps HIV levels suppressed and how the drug moves through the body. Participants are adults with both HIV and TB who have not yet started HIV treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dolutegravir, an HIV drug, taken once daily with food or twice daily
What this could lead to
If the once-daily-with-food approach works, it could simplify HIV treatment for people who also take rifampin-based TB therapy, making it easier to stick with both treatments.
What could go wrong
This is a small Phase 2 trial in Thai patients, so the results may not apply to everyone. The once-daily dose might not control HIV as well as the twice-daily dose, and food could affect the drug in unexpected ways.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

123 people

The number who actually took part.

Started

Jun 2019

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. documented HIV positive 2. Aged \>18 years 3. ARV naïve (previous exposure to ARV for \< 2 weeks) 4. Any CD4 cell count 5. ALT \<5 times ULN 6. estimated GFR\>60 ml/min/1.73m2 7. Hemoglobin \>7 mg/L 8. 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 9. No other active OI (CDC class C event) except oral candidiasis or disseminated MAC 10. Body weight \>40kg 11. Able to provide written informed consent Exclusion Criteria: 1. Have documented history of HIV treatment failure or HIV mutation to NRTI, NNRTI, and/or INIs 2. Have previously treated for tuberculosis 3. Currently using immunosuppressive agents. 4. Currently using any prohibited medications that can affect the pharmacokinetics of the study drug such as phenobarbital, and carbamazepine 5. Currently using alcohol or illicit substances that may affect the conduct of the trial as per the opinion of the site Principal Investigator 6. Unlikely to be able to remain in the follow-up period as defined by the protocol 7. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN. 8. Have Karnofsky performance score \<30% 9. Have TB meningitis, bone/joints (due to prolonged use of anti-TB drug) 10. Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

HIV infectious disease tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV/TB coinfection

Contacts and locations

Locations

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, Changwat Nonthaburi, 11000, Thailand

  • Bhumibol Adulyadej Hospital

    Bangkok, Bangkok, 10220, Thailand

  • Chest Division, Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330, Thailand

  • HIV-NAT, Thai Red Cross - AIDS Research Centre

    Bangkok, 10330, Thailand

  • Infectious Disease Buddhachinaraj Phitsanulok Hospital

    Phitsanulok, Changwat Phitsanulok, 65000, Thailand

  • Infectious Disease Chiangrai Prachanukroh Hospital

    Chiang Rai, Chiangrai, 57000, Thailand

  • Infectious Disease Chonburi Hospital

    Chon Buri, Changwat Chon Buri, 20000, Thailand

  • Infectious Disease Taksin Hospital

    Bangkok, Bangkok, 10600, Thailand

  • Infectious Disease, Chulalongkorn University

    Bangkok, Bangkok, 10330, Thailand

  • Klang Hospital

    Bangkok, Bangkok, 10100, Thailand

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