TuberculosisPhase 3DOVETAILNCT06497465
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
A Phase 3 study testing Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] and Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) in people with Tuberculosis and HIV, run by Johns Hopkins University at 5 sites in Brazil.
Trial summary
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard… Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] and Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesBrazil
- Study dates
- 18 Sep 2025to 31 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 viral load ≥1000 copies/mL
- ART-naïve.
- Documentation of pulmonary TB identified by:
- At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay [LPA]), and RIF resistance not detected.
- OR Culture positive for MTB OR Positive Urinary Lipoarabinomannan (LAM) testing OR Clinical diagnosis of tuberculosis with no microbiological confirmation
Who cannot join
- Pregnant, or plans to become pregnant.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kate Boehner, RN contact
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Recruiting
Instituto Tropical de Doenças Infecciosas Manaus
Manaus, Amazonas, 69040-000
Marcus Lacerda, MD, PhD, +55 92 99114-7633, marcuslacerda.br@gmail.com
Marcelo Cordeiro,,MD, PhD, +55 92 98533-3533
- Recruiting
CePClin - Center for Studies and Research in Infectious Diseases Ltda
Natal, Rio Grande do Norte, 59.025-050
Mônica Bay B Bay, MD, +55 84 994141921, monibay@gmail.com
Sibele F Araújo, sibelearaujo@cpclinrn.com.br
- Recruiting
FIOCruz
Rio de Janeiro, Rio de Janeiro, 21040-360
Valeria Rolla, MD, +55 21 99490-4251, valeria.rolla@ini.fiocruz.br
Aline Benjamin, PhD, alinebenjaminipec@gmail.com
- Recruiting
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Rio de Janeiro, 26210-190
Aline Ramalho, MD, +55 22 996107788, alineramalhopesquisa@gmail.com
Aline Ramalho, MD
- Recruiting
Universidade Federal da Bahia
Salvador, Estado de Bahia, 40110-160
Carlos Brites, MD, PhD, +55 71 992329552, crbrites@gmail.com
Carlos Brites, MD, PhD
About this study
Official title: Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy
Read the detailed description
Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) < 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 >50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).
The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).
- Conditions
- Tuberculosis, HIV
- Being tested
- Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50mg TabDrug
Also called TIVICAY 50 mg, TIVICAY PD
Participants will receive Dolutegravir 50mg
Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]Drug
Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)Drug
Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID) | Experimental | Arm 1: DTG 50mg/3TC 300 mg fixed-dose-combination (FDC) tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then DTG 50mg/3TC 300 mg FDC tablet (Dovato®) once daily to week 52 Receives: Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] |
| Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening | Experimental | Arm 2: DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52 Receives: Drug: Dolutegravir 50mg Tab; Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] |
| Arm 3: Standard of Care 3-drug ART (DTG+ TDF/3TC) plus DTG 50mg in the evening. | Active comparator | Arm 3: Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then DTG 50 mg + TDF/3TC FDC tablet once daily to week 52 Receives: Drug: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm
To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.
Measured: 28 weeks
Secondary outcomes (6)
1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm
To compare the proportion in each arm above DTG protein adjusted 90% inhibitory concentration (IC90) (64 ng/mL) at each PK sampling.
Measured: 48 weeks
1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)
To compare the proportion of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)
Measured: 48 weeks
1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm
To compare the changes from baseline over 28 weeks and 48 weeks of HIV treatment by the arm.
Measured: 28 weeks, 48 weeks
1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL
1-To estimate the pharmacokinetics (PK) of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with rifampicin (RIF)-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.
Measured: 2years
1.3.4 Concentration of the PK of DTG
Concentration of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with RIF-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.
Measured: 2years
1.3.5 Compare Grade 3 or 4 adverse events, by arm
To compare the Grade 3 \& 4 adverse events by arm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start18 Sep 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1(n=50): DTG 50mg/3TC 300 mg FDC tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then Dolutegravir (DTG) 50mg / lamivudine (3TC) 300 mg fixed dose combination (FDC) tablet (Dovato®) once daily to week 52 Arm 2(n=50): DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52 Arm 3(n=50): Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then Dolutegravir (DTG) 50 mg + Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) FDC tablet once daily to week 52
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Ethel M Weld, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497465
- Sponsor's protocol ID
- IRB00441778
- Acronym
- DOVETAIL
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2024
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment
- ClinicalTrials.gov ID
- NCT06497465
- Acronym / sponsor ID
- DOVETAIL / IRB00441778
- Conditions
- Tuberculosis, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 11 Jul 2024 (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.
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy
Detailed description
Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) < 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 >50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).
The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Arm 1(n=50): DTG 50mg/3TC 300 mg FDC tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then Dolutegravir (DTG) 50mg / lamivudine (3TC) 300 mg fixed dose combination (FDC) tablet (Dovato®) once daily to week 52 Arm 2(n=50): DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52 Arm 3(n=50): Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then Dolutegravir (DTG) 50 mg + Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) FDC tablet once daily to week 52
| Arm | Type | Receives |
|---|---|---|
| Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID) | Experimental | Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]Arm 1: DTG 50mg/3TC 300 mg fixed-dose-combination (FDC) tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then DTG 50mg/3TC 300 mg FDC tablet (Dovato®) once daily to week 52 |
| Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening | Experimental | Drug: Dolutegravir 50mg Tab, Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]Arm 2: DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52 |
| Arm 3: Standard of Care 3-drug ART (DTG+ TDF/3TC) plus DTG 50mg in the evening. | Active comparator | Drug: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)Arm 3: Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then DTG 50 mg + TDF/3TC FDC tablet once daily to week 52 |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 viral load ≥1000 copies/mL
- ART-naïve.
- Documentation of pulmonary TB identified by:
Key exclusion criteria (1 listed)
- Pregnant, or plans to become pregnant.
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 50mg TabAlso: TIVICAY 50 mg, TIVICAY PDParticipants will receive Dolutegravir 50mg | Drug | Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening |
| Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] | Drug | Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID), Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the evening |
| Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) | Drug | Arm 3: Standard of Care 3-drug ART (DTG+ TDF/3TC) plus DTG 50mg in the evening. |
Primary outcome
Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm
Time frame: 28 weeks
To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.
6 secondary outcomes
1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm
Time frame: 48 weeks
1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)
Time frame: 48 weeks
1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm
Time frame: 28 weeks, 48 weeks
1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL
Time frame: 2years
1.3.4 Concentration of the PK of DTG
Time frame: 2years
1.3.5 Compare Grade 3 or 4 adverse events, by arm
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Kate Boehner, RN contact
Ethel M Weld, MD principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] and Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) in people with Tuberculosis and HIV, run by Johns Hopkins University at 5 sites in Brazil.
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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 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 5 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz M Kohler, RN (410 614 3812, bkohler@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm (time frame: 28 weeks). 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 11 Sep 2026.