HIV-associated TuberculosisPhase 2NCT05630872
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
A Phase 2 study testing Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC and 2HPZM in people with HIV-associated Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-associated Tuberculosis
- What is being tested?
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC and 2HPZM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Feb 2024to 12 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Weight ≥40 kg.
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
- Documentation of HIV-1 status.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry at any network-approved non-US laboratory that is IQA certified.
- ART-naïve or not on ART for 12 consecutive weeks prior to TB diagnosis.
- Willingness and eligibility to start DTG-based ART at 6 weeks, with a window of ±1 week, after starting TB treatment, with no intention to change ART for the duration of the study.
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- Documentation of pulmonary TB.
- Willingness to start 2HPZM/2HPM therapy for DS-TB.
- The following laboratory values obtained within 30 days prior to study entry:
- Absolute neutrophil count (ANC) >750 cells/mm3
- Hemoglobin ≥7.4 g/dL
- Platelet count ≥50,000/mm3
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) <2.5 X the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) <2.5 x ULN
- Total bilirubin ≤1.5 x ULN
- Creatinine <1.3 x ULN
- For participants who can become pregnant, negative serum or urine pregnancy test at screening within 30 days prior to entry and within 48 hours prior to entry.
- Participants who can become pregnant must agree not to participate in the conception process and if participating in sexual activity that could lead to pregnancy, must agree to use one reliable nonhormonal method of contraception.
- Documentation of Karnofsky performance score ≥50 within 30 days prior to entry.
Who cannot join
- Breastfeeding, pregnant, or plans to become pregnant.
- Known allergy/sensitivity or any hypersensitivity to components of the study drugs, or their formulations.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Requirement for ongoing use of drugs that are known to have significant drug-drug interactions with DTG or RPT.
- Known history of acute intermittent porphyria.
- Previous treatment for active TB disease within 6 months preceding initiation of study drugs.
Show all 13Show fewer
- More than 5 days of treatment directed against active TB for the current TB episode preceding study entry.
- At the time of study entry, documentation of an M. tuberculosis isolate from the current or previous treatment episode known to be resistant to RIF or INH.
- Known history of prolonged QT syndrome.
- Known cirrhosis, a history of decompensated liver disease (ascites, hepatic encephalopathy, or esophageal varices).
- Documentation of severe opportunistic infections, in the opinion of the site investigator, within 3 months of study entry.
- Documentation of severe extra-pulmonary TB (e.g., meningitis, osteomyelitis, disseminated TB) at the time of screening.
- Acute gout at the time of screening.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Africa3 sites
University of Cape Town Lung Institute (UCTLI) CRS (Site # 31792)
Mowbray, Cape Town, Western Cape, 7700
Durban International CRS (Site # 11201)
Wentworth, Durban, 4052
South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site # 31793)
Worcester, Western Cape, 6850
Thailand1 site
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site # 31802)
Bangkok, 10330
About this study
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).
Read the detailed description
This was an open-label, single arm, phase II, multicenter pharmacokinetic (PK) study to investigate the effect of daily RPT 1200 mg on DTG exposure in participants with HIV-associated TB. Adults with HIV with newly diagnosed drug susceptible tuberculosis (DS-TB) who were not on antiretroviral therapy (ART) were recruited around the time of DS-TB diagnosis. At study entry, daily rifapentine (R) and moxifloxacin (M) plus isoniazid (H) and pyrazinamide (P) was initiated for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks for anti-tuberculosis (anti-TB) therapy. This regimen is known as the 2HPZM/2HPM regimen. DTG-based ART at 50 mg twice daily (BID) was started after 6 weeks of TB therapy. DTG 50 mg BID was continued for 2 weeks after completion of TB therapy, after which DTG was reduced to standard dose 50 mg once daily (QD).
Intensive PK sampling was performed at study week 8 (2 weeks after initiating DTG-based ART) and week 21 (2 weeks after reducing DTG to once daily) to obtain full plasma PK profiles for DTG during and after RPT co-administration.
HIV-1 viral load was measured to assess for viral suppression at study entry (pre-ART), at weeks 10 and 14 (while on RPT/DTG therapy), at week 21, week 30 (24 weeks after initiating ART and 13 weeks after completion of TB treatment), and at week 48.
Safety monitoring included hematology and liver/renal function testing at each study visit, plus clinical assessments for rifamycin hypersensitivity syndrome, and drug-induced liver injury.
- Conditions
- HIV-associated Tuberculosis
- Being tested
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM, 2HPM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TCDrug
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.
DTG 50 mg orally QD plus TDF/3TCDrug
DTG 50 mg orally QD plus TDF/3TC from two weeks after completion of TB treatment to end of study (week 48).
2HPZMDrug
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.
2HPMDrug
Daily regimen of rifapentine 1200mg, moxifloxacin 400mg, and isoniazid 300mg from study week 8 through study week 17.
| Study group | Role | What they receive |
|---|---|---|
| Adults with HIV and newly diagnosed DS-TB not currently on ART | Experimental | Participants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry.
DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy.
Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD. Receives: Drug: Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC; Drug: DTG 50 mg orally QD plus TDF/3TC; Drug: 2HPZM; Drug: 2HPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model-simulated 5th Percentile and Corresponding 95% Confidence Interval of DTG Cmin at 50 mg BID When Co-administered With Daily RPT 1200 mg Plus HZM
Model-simulated 5th percentile and corresponding 95% confidence interval of dolutegravir (DTG) minimum concentrations (Cmin) at 50 mg BID (twice daily) when co-administered with daily rifapentine (RPT) 1200 mg plus HZM (isoniazid, pyrazinamide, and ethambutol). Pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling (FOCE-I). The final model was used to simulate 10000 individuals, incorporating parameter uncertainty. Covariates included fat-free mass on disposition parameters, rifapentine on clearance and bioavailability, and baseline unconjugated bilirubin on clearance. Measurements were taken at steady state, which was assumed to be achieved after at least 5 half-lives.
Measured: Measured at week 8 and week 21. Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
Secondary outcomes (10)
DTG Minimum Concentration (Cmin)
Primary pharmacokinetic (PK) parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Measured: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Maximum Concentration (Cmax)
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Measured: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Area Under the Concentration-time Curve (AUC0-24)
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Measured: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Clearance
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Measured: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Terminal Half Life
Primary pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling. Secondary model-predicted parameters were derived post-hoc via simulations in R using the mrgsolve package.
Measured: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
Percent of Participants Who Experienced Grade 3 or Higher Adverse Events (AE)
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Measured: Week 6 through week 17
Percent of Participants Who Experienced Rifamycin Hypersensitivity
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17.
Measured: Week 6 through week 17
Percent of Participants Who Experienced Drug-induced Liver Injury
Drug-induced liver injury was defined as alanine animotransferase (ALT) ≥3xULN (upper limit of normal) with symptoms/jaundice or ALT ≥5xULN.
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17.
Measured: Week 6 through week 17
Percent of Participants Who Prematurely Discontinued Study Treatment
The time frame specifically encompasses the time period the participants were on both ART and TB treatment which was scheduled to occur between study weeks 6 and 17. Study treatment discontinuation included discontinuing either ART, TB treatment, or both.
Measured: Week 6 through week 17
Percent of Participants With Viral Suppression
Viral suppression is defined as HIV-1 RNA below 50 copies/mL.
Measured: Weeks 10, 14, 21, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start13 Feb 2024
- Primary completion7 May 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-associated TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ViiV Healthcare, Mylan Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630872
- Sponsor's protocol ID
- A5406
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2022
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
- ClinicalTrials.gov ID
- NCT05630872
- Acronym / sponsor ID
- A5406
- Conditions
- HIV-associated Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- ViiV Healthcare, Mylan Inc.
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This was an open-label, single arm, phase II, multicenter pharmacokinetic (PK) study to investigate the effect of daily RPT 1200 mg on DTG exposure in participants with HIV-associated TB. Adults with HIV with newly diagnosed drug susceptible tuberculosis (DS-TB) who were not on antiretroviral therapy (ART) were recruited around the time of DS-TB diagnosis. At study entry, daily rifapentine (R) and moxifloxacin (M) plus isoniazid (H) and pyrazinamide (P) was initiated for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks for anti-tuberculosis (anti-TB) therapy. This regimen is known as the 2HPZM/2HPM regimen. DTG-based ART at 50 mg twice daily (BID) was started after 6 weeks of TB therapy. DTG 50 mg BID was continued for 2 weeks after completion of TB therapy, after which DTG was reduced to standard dose 50 mg once daily (QD).
Intensive PK sampling was performed at study week 8 (2 weeks after initiating DTG-based ART) and week 21 (2 weeks after reducing DTG to once daily) to obtain full plasma PK profiles for DTG during and after RPT co-administration.
HIV-1 viral load was measured to assess for viral suppression at study entry (pre-ART), at weeks 10 and 14 (while on RPT/DTG therapy), at week 21, week 30 (24 weeks after initiating ART and 13 weeks after completion of TB treatment), and at week 48.
Safety monitoring included hematology and liver/renal function testing at each study visit, plus clinical assessments for rifamycin hypersensitivity syndrome, and drug-induced liver injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with HIV and newly diagnosed DS-TB not currently on ART | Experimental | Drug: Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, Drug: DTG 50 mg orally QD plus TDF/3TC, Drug: 2HPZM, Drug: 2HPMParticipants received daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide for 8 weeks followed by daily rifapentine-moxifloxacin plus isoniazid for 9 weeks (referred to as 2HPZM/2HPM) for anti-TB therapy at study entry. DTG-based ART at 50 mg BID was started after 6 weeks of TB therapy and continued for 2 weeks after completion of TB therapy. Two weeks after completion of TB therapy DTG was reduced to standard dose 50 mg QD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Weight ≥40 kg.
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
- Documentation of HIV-1 status.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry at any network-approved non-US laboratory that is IQA certified.
- ART-naïve or not on ART for 12 consecutive weeks prior to TB diagnosis.
Key exclusion criteria (13 listed)
- Breastfeeding, pregnant, or plans to become pregnant.
- Known allergy/sensitivity or any hypersensitivity to components of the study drugs, or their formulations.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Requirement for ongoing use of drugs that are known to have significant drug-drug interactions with DTG or RPT.
- Known history of acute intermittent porphyria.
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 |
|---|---|---|
| Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TCDolutegravir (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 | Adults with HIV and newly diagnosed DS-TB not currently on ART |
| DTG 50 mg orally QD plus TDF/3TCDTG 50 mg orally QD plus TDF/3TC from two weeks after completion of TB treatment to end of study (week 48). | Drug | Adults with HIV and newly diagnosed DS-TB not currently on ART |
| 2HPZMDaily 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 | Adults with HIV and newly diagnosed DS-TB not currently on ART |
| 2HPMDaily regimen of rifapentine 1200mg, moxifloxacin 400mg, and isoniazid 300mg from study week 8 through study week 17. | Drug | Adults with HIV and newly diagnosed DS-TB not currently on ART |
Primary outcome
Model-simulated 5th Percentile and Corresponding 95% Confidence Interval of DTG Cmin at 50 mg BID When Co-administered With Daily RPT 1200 mg Plus HZM
Time frame: Measured at week 8 and week 21. Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
Model-simulated 5th percentile and corresponding 95% confidence interval of dolutegravir (DTG) minimum concentrations (Cmin) at 50 mg BID (twice daily) when co-administered with daily rifapentine (RPT) 1200 mg plus HZM (isoniazid, pyrazinamide, and ethambutol). Pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling (FOCE-I). The final model was used to simulate 10000 individuals, incorporating parameter uncertainty. Covariates included fat-free mass on disposition parameters, rifapentine on clearance and bioavailability, and baseline unconjugated bilirubin on clearance. Measurements were taken at steady state, which was assumed to be achieved after at least 5 half-lives.
10 secondary outcomes
DTG Minimum Concentration (Cmin)
Time frame: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Maximum Concentration (Cmax)
Time frame: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Area Under the Concentration-time Curve (AUC0-24)
Time frame: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Clearance
Time frame: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
DTG Terminal Half Life
Time frame: Measured at week 8 and week 21; Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.
Percent of Participants Who Experienced Grade 3 or Higher Adverse Events (AE)
Time frame: Week 6 through week 17
Percent of Participants Who Experienced Rifamycin Hypersensitivity
Time frame: Week 6 through week 17
Percent of Participants Who Experienced Drug-induced Liver Injury
Time frame: Week 6 through week 17
Percent of Participants Who Prematurely Discontinued Study Treatment
Time frame: Week 6 through week 17
Percent of Participants With Viral Suppression
Time frame: Weeks 10, 14, 21, and 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC and 2HPZM in people with HIV-associated Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
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 19 inclusion and 13 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, 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?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Model-simulated 5th Percentile and Corresponding 95% Confidence Interval of DTG Cmin at 50 mg BID When Co-administered With Daily RPT 1200 mg Plus HZM (time frame: Measured at week 8 and week 21. Samples were drawn pre-dose and at 1, 2, 4, 6, 8-10, and 24 hours (but prior to next dose) post-dosing.). 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 20 Jul 2026.