A Phase 4 interventional study of Dolutegravir 50 MG and Dolutegravir 10 MG in Tuberculosis and Hiv, sponsored by University of KwaZulu. Recruiting at 1 site in South Africa. Open to participants aged 23 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by University of KwaZulu · Phase 4, Interventional, and Treatment
Among 210 studies in Tuberculosis with a site in South Africa — 21 open to participants now, 35 under way, 8 of them phase 3. Tuberculosis · South Africa.
Among the 210 studies in Tuberculosis with a site in South Africa, this one is the 170th largest by planned enrollment of the 176 interventional ones, is one of 19 that started in 2021, is one of 9 in phase 4, reaches primary completion later than 4 of the 34 other live ones, and was the 158th registered.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 20 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →21 of the 210 studies in Tuberculosis with a site in South Africa are open now, in 12 countries. Each count lists the studies.
Of the 109 Tuberculosis studies recruiting now, 64 (59%) set no upper age limit and 35 (32%) stop at 75 or younger; 48 take children under 18; 30 take healthy volunteers.
This study: 23 Months to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →210 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 19 started in 2021.
Median enrollment 214 across the 176 interventional studies, 770 across the 34 observational. Of the 161 that completed or were terminated, 64 (40%) have results posted.
24 of 210 have an industry lead sponsor. The 10 most frequent:
University of KwaZulu is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
University of KwaZulu has 1 study filed under Tuberculosis — fewer than ten, so there is no comparison to draw.
10 of the studies in Tuberculosis with a site in South Africa that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03568383Phase 3National Institute of Allergy and Infectious Diseases (NIAID)Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients | 2026-11-16 |
| NCT06253715Phase 3Johns Hopkins UniversityShortened Regimen for Drug-susceptible TB in Children | 2027-09-30 |
| NCT06050356Statens Serum InstitutFirst-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b | 2026-12 |
| NCT03851159University of StellenboschNyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota | 2026-12-31 |
| NCT05842161Massachusetts General HospitalSouth Africa Smoking Cessation and Engagement in HIV/TB Care Care | 2027-05-01 |
Among the 210 studies in Tuberculosis with a site in South Africa, from their registry updates:
Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF.
Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG
This is a single centre, open-label, non-randomised, prospective study evaluating the steady-state pharmacokinetics of twice-daily dose DTG administered during concurrent RIF treatment and assessing safety and tolerance in HIV-TB co-infected children weighing 20 to 35 kg.
DTG will be administered as a twice-daily dose 50mg tablet formulation both before starting and after completion of the standard six-month RIF-based anti-TB treatment. The NRTI background and anti-TB drugs will be prescribed following the national weight band dosing guidelines.
Those initially diagnosed with TB are likely to be sicker, and the recommendation is to start anti-TB treatment first and follow with ART two weeks later.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twice daily Dolutegravir (50mg) with Rifampicin containing TB treatment / Twice daily Dolutegravir (10mg) dispersible
Drug: Dolutegravir 50 MG · Drug: Dolutegravir 10 MG
Twice daily dolutegravir with rifampicin containing TB treatment
Twice daily dolutegravir with rifampicin containing TB treatment
Pharmacokinetics (Ctrough) of DTG 50mg twice daily
Description of the pharmacokinetics (Ctrough, Cmax and AUC0-24h) of DTG 50mg twice daily in children (20-35kg) who are taking rifampicin-based regimen for the treatment of tuberculosis.
Time frame: 48 weeks
Pharmacokinetics (Cmax) of DTG 50mg twice daily
Description of the pharmacokinetics (Cmax) of DTG 50mg twice daily in children (20-35kg) who are taking rifampicin-based regimen for the treatment of tuberculosis.
Time frame: 48 weeks
Pharmacokinetics (AUC0-24h) of DTG 50mg twice daily
Description of the pharmacokinetics (AUC0-24h) of DTG 50mg twice daily in children (20-35kg) who are taking rifampicin-based regimen for the treatment of tuberculosis.
Time frame: 48 weeks
To develop an integrated model which will be used to estimate the primary PK parameters of DTG
Nonlinear mixed-effects models (NLMEM) will be used to describe the PK of DTG in an integrated model which will be used to estimate the primary PK parameters of DTG. The effect of concomitant TB treatment, as well as other covariates on these parameters, will be evaluated in the model.
Time frame: 48 weeks
Adverse events
Subjects will be monitored clinically and biologically for safety. Biological monitoring will focus on liver function. Adverse Events and Serious Adverse Events will be graded following DAIDS grading tables
Time frame: 48 weeks
Virological suppression
Antiretroviral efficacy is based on HIV viral suppression. The cut-off value related to virological failure is defined as a viral load superior to 400 copies per mL, confirmed within a month. Viral load will be assessed as per the SOE
Time frame: 48 weeks
Enzyme polymorphisms
Enzyme polymorphism analysis will be conducted at a later stage from stored samples to determine the importance of polymorphisms in genes regulating anti-TB drug and antiretroviral concentrations and effects in the study population.
Time frame: 48 weeks
Started Aug 2021 (actual). Primary completion is estimated for Jul 2025, 47 months after the start.
Of 22 phase 4 interventional studies under Tuberculosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 47. This study's planned 47 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Dolutegravir
University of KwaZulu