HIV/TB CoinfectionPhase 2NCT03731559
Efficacy, Safety and Pharmacokinetics of DTG With RIF
A Phase 2 study testing DTG 50 mg OD with food and DTG 50 mg BID in people with HIV/TB Coinfection, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/TB Coinfection
- What is being tested?
- DTG 50 mg OD with food and DTG 50 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 10 sitesThailand
- Study dates
- 25 Jun 2019to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Thailand10 sites
Klang Hospital
Bangkok, Bangkok, 10100
Bhumibol Adulyadej Hospital
Bangkok, Bangkok, 10220
Infectious Disease, Chulalongkorn University
Bangkok, Bangkok, 10330
Infectious Disease Taksin Hospital
Bangkok, Bangkok, 10600
Chest Division, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, 10330
Infectious Disease Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, 57000
Infectious Disease Chonburi Hospital
Chon Buri, Changwat Chon Buri, 20000
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, 11000
Infectious Disease Buddhachinaraj Phitsanulok Hospital
Phitsanulok, Changwat Phitsanulok, 65000
About this study
Official title: Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 mg Once Daily With Food Versus Dolutegravir 50 mg Twice Daily in HIV/TB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy
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.
Read the detailed description
This is a Stage II, randomized, open-label study describing the efficacy and safety of DTG 50 mg OD with food and DTG 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy. The study will be conducted in approximately 200 HIV-1 infected individuals who are ART-naïve and newly diagnosed with probable or confirmed pulmonary, pleural, or lymph node (LN) Mycobacterium TB (MTB) taking RIF-containing first-line TB treatment. Subjects should have confirmed RIF-sensitive MTB infection as determined by GeneXpert (or equivalent approved molecular test) or mycobacterial culture.
The study is comprised two different stages:
- Stage1, investigators will test the safety and tolerability, as well as Pharmacokinetics (PK), of two different doses of dolutegravir co-administered with standard anti-TB treatment. Overall, 40 HIV/TB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). Intensive PK of DTG will be performed at week 4. Interim analysis will be performed if all 40 cases completed 12 weeks and 24 weeks. Premature study termination will be set for
- proportion of HIV RNA < 50 copies/ml at week 24 between 2 group is different > 20%
- DTG 50 mg with food has geometric mean DTG Ctrough < 0.3 mg/L If there is no premature study termination met, the study will move to stage 2. Stage 2 will only be recruited if two different doses of dolutegravir are well tolerated and safe.
- Stage 2: 160 HIV/TB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). DTG concentration will be performed at week 4 and 48. Interim analysis will be performed if all 200 cases completed 24 weeks.
- Conditions
- HIV/TB Coinfection
- Being tested
- DTG 50 mg OD with food, DTG 50 mg BID
- Keywords
- Efficacy, safety, pharmacokinetics, Dolutegravir, HIV/TB co-infected patients, rifampin-based antituberculosis therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 BIDDrug
Dolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: DTG 50 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (23)
AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Measured: Week 4
Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Measured: Week 4
Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Measured: Week 4
Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Measured: Week 4
Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24
Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24
Measured: Week 24
Changes in CD4+ counts from baseline to Week 24 and Week 48
Changes in CD4+ counts from baseline to Week 24 and Week 48
Measured: Weeks 24 and 48
Incidence of disease progression
Incidence of disease progression (HIV-associated conditions, new AIDS diagnoses, and death)
Measured: Week 48
Proportion of subjects that have completed TB treatment
Proportion of subjects that have completed TB treatment
Measured: Week 48
Proportion of subjects that are cured from TB
Proportion of subjects that are cured from TB
Measured: Week 48
Proportion of subjects that have relapsed
Proportion of subjects that have relapsed
Measured: Week 48
Proportion of subjects that have defaulted
Proportion of subjects that have defaulted
Measured: Week 48
TB outcome in terms of cure
Number of participants that have been cured of TB
Measured: Week 48
TB outcome in terms of relapse
Number of participants with relapse
Measured: Week 48
TB outcome in terms of treatment failure due to TB resistance
Number of participants with treatment failure due to TB resistance
Measured: Week 48
TB outcome in terms of incidence
Incidence of all AEs, SAEs, and laboratory abnormalities
Measured: Week 48
TB outcome in terms of severity
Severity of all AEs, SAEs, and laboratory abnormalities
Measured: Week 48
discontinuation from the study
Proportion of subjects who permanently discontinued randomization arm due to AEs or death
Measured: Week 48
discontinuation from the study drugs
Proportion of subjects who temporarily discontinued the study drugs and/or TB therapy due to AEs
Measured: Week 48
Proportion of subjects with TB-associated IRIS
Proportion of subjects with TB-associated IRIS
Measured: Week 48
AUC of DTG at Weeks 4 (with RIF) and 48 (without RIF)
AUC of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate AUC
Measured: Weeks 4 and 48
Cmax of DTG at Weeks 4 (with RIF) and 48 (without RIF)
Cmax of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate Cmax
Measured: Weeks 4 and 48
Ctrough of DTG at Weeks 4 (with RIF) and 48 (without RIF)
Ctrough of DTG at Weeks 4 (with RIF) and 48 (without RIF) will be analyzed using population PK modeling approach to estimate Ctrough
Measured: Weeks 4 and 48
proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48
proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48 (viral suppression)
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start25 Jun 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/TB CoinfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute, Bhumibol Adulyadej Hospital, Infectious Disease Taksin Hospital, Klang Hospital, Infectious Disease Chiangrai Prachanukroh Hospital, Infectious Disease Chonburi Hospital, Infectious Disease Buddhachinaraj Phitsanulok Hospital, Radboud University Medical Center, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Anchalee Avihingsanon, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731559
- Sponsor's protocol ID
- HIV-NAT 254
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2018
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 mg Once Daily With Food Versus Dolutegravir 50 mg Twice Daily in HIV/TB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy
- ClinicalTrials.gov ID
- NCT03731559
- Acronym / sponsor ID
- HIV-NAT 254
- Conditions
- HIV/TB Coinfection
- Keywords
- Efficacy, safety, pharmacokinetics, Dolutegravir, HIV/TB co-infected patients, rifampin-based antituberculosis therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute, Bhumibol Adulyadej Hospital, Infectious Disease Taksin Hospital, Klang Hospital, Infectious Disease Chiangrai Prachanukroh Hospital, Infectious Disease Chonburi Hospital, Infectious Disease Buddhachinaraj Phitsanulok Hospital, Radboud University Medical Center, Ministry of Health, Thailand
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Stage II, randomized, open-label study describing the efficacy and safety of DTG 50 mg OD with food and DTG 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy. The study will be conducted in approximately 200 HIV-1 infected individuals who are ART-naïve and newly diagnosed with probable or confirmed pulmonary, pleural, or lymph node (LN) Mycobacterium TB (MTB) taking RIF-containing first-line TB treatment. Subjects should have confirmed RIF-sensitive MTB infection as determined by GeneXpert (or equivalent approved molecular test) or mycobacterial culture.
The study is comprised two different stages:
- Stage1, investigators will test the safety and tolerability, as well as Pharmacokinetics (PK), of two different doses of dolutegravir co-administered with standard anti-TB treatment. Overall, 40 HIV/TB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). Intensive PK of DTG will be performed at week 4. Interim analysis will be performed if all 40 cases completed 12 weeks and 24 weeks. Premature study termination will be set for
- proportion of HIV RNA < 50 copies/ml at week 24 between 2 group is different > 20%
- DTG 50 mg with food has geometric mean DTG Ctrough < 0.3 mg/L If there is no premature study termination met, the study will move to stage 2. Stage 2 will only be recruited if two different doses of dolutegravir are well tolerated and safe.
- Stage 2: 160 HIV/TB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). DTG concentration will be performed at week 4 and 48. Interim analysis will be performed if all 200 cases completed 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTG 50 mg OD with food | Active comparator | Drug: DTG 50 mg OD with foodDTG 50 mg OD with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy. |
| DTG 50 mg BID | Active comparator | Drug: DTG 50 mg BIDDTG 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- documented HIV positive
- Aged >18 years
- ARV naïve (previous exposure to ARV for < 2 weeks)
- Any CD4 cell count
- ALT <5 times ULN
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTG 50 mg OD with foodDolutegravir 50 mg once daily 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 BIDDolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy. | Drug | DTG 50 mg BID |
Primary outcome
proportion of subjects from the ITT analysis population with plasma HIV-1 RNA <50 c/mL at Week 24
Time frame: 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.
23 secondary outcomes
AUC of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Time frame: Week 4
Cmax of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Time frame: Week 4
Cmin of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Time frame: Week 4
Oral clearance of DTG concentration between DTG 50 mg with food OD and DTG 50 mg BID
Time frame: Week 4
Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24
Time frame: Week 24
Changes in CD4+ counts from baseline to Week 24 and Week 48
Time frame: Weeks 24 and 48
Incidence of disease progression
Time frame: Week 48
Proportion of subjects that have completed TB treatment
Time frame: Week 48
Proportion of subjects that are cured from TB
Time frame: Week 48
Proportion of subjects that have relapsed
Time frame: Week 48
Proportion of subjects that have defaulted
Time frame: Week 48
TB outcome in terms of cure
Time frame: Week 48
TB outcome in terms of relapse
Time frame: Week 48
TB outcome in terms of treatment failure due to TB resistance
Time frame: Week 48
TB outcome in terms of incidence
Time frame: Week 48
TB outcome in terms of severity
Time frame: Week 48
discontinuation from the study
Time frame: Week 48
discontinuation from the study drugs
Time frame: Week 48
Proportion of subjects with TB-associated IRIS
Time frame: Week 48
AUC of DTG at Weeks 4 (with RIF) and 48 (without RIF)
Time frame: Weeks 4 and 48
Cmax of DTG at Weeks 4 (with RIF) and 48 (without RIF)
Time frame: Weeks 4 and 48
Ctrough of DTG at Weeks 4 (with RIF) and 48 (without RIF)
Time frame: Weeks 4 and 48
proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anchalee Avihingsanon, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DTG 50 mg OD with food and DTG 50 mg BID in people with HIV/TB Coinfection, run by The HIV Netherlands Australia Thailand Research Collaboration at 10 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of subjects from the ITT analysis population with plasma HIV-1 RNA <50 c/mL at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.