Trial reportThe lancet. HIV2023
Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trial.
Trial report in The lancet. HIV, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis: a Phase 2 Non-comparative Randomised Controlled Trial
Shortened Regimen for Drug-susceptible TB in Children
Who cites it
22 citing papers in PubMed, 39 citations in OpenAlex.
- Trial
- Pharmacokinetics and safety of dolutegravir in children receiving rifampicin tuberculosis treatment in South Africa (ORCHID): a prospective cohort study.The lancet. HIV · 2025Trial
- Twice-Daily Dolutegravir-Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Pharmacokinetics of Efavirenz in Pregnancy and Postpartum with and Without First-line Tuberculosis Drugs: Results from IMPAACT P1026s.Clinical pharmacokinetics · 2026Article
- Population Pharmacokinetic Modelling of Dolutegravir: A Narrative Review.Clinical pharmacokinetics · 2026Review
- Dolutegravir concentrations in children receiving 3-month weekly isoniazid and rifapentine (3HP) for tuberculosis prevention.Microbiology spectrum · 2026Observational
- Reduced Metformin Concentrations in Obese Women With Human Immunodeficiency Virus Treated With Dolutegravir.The Journal of infectious diseases · 2025Observational
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
- Tuberculosis disease among people with HIV: therapeutic advances.The lancet. HIV · 2025Review
- Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study.Clinical pharmacology and therapeutics · 2025Article
- Treating HIV-associated tuberculosis in children without compromise.The lancet. HIV · 2025Article
- Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Observational
- Tuberculosis Preventive Treatment in High TB-Burden Settings: A State-of-the-Art Review.Drugs · 2025Review
- Establishment of antiretroviral pediatric registry: efforts toward achieving the UNAIDS 95-95-95 targets in the Free State Province, South Africa.Frontiers in public health · 2025Article
- The population pharmacokinetics of dolutegravir co-administered with rifampicin in Thai people living with HIV: Assessment of alternative dosing regimens.CPT: pharmacometrics & systems pharmacology · 2025Article
- An update on drug-drug interactions in older adults living with human immunodeficiency virus (HIV).Expert review of clinical pharmacology · 2024Review
- Advances in Antiretroviral Therapy for Patients with Human Immunodeficiency Virus-Associated Tuberculosis.Viruses · 2024Review
- Prevalence of Emergent Dolutegravir Resistance Mutations in People Living with HIV: A Rapid Scoping Review.Viruses · 2024Article
- Advancing Diagnosis and Treatment in People Living with HIV and Tuberculosis Meningitis.Current HIV/AIDS reports · 2023Review
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 3 countries.
Funding
Abstract
backgroundThe drug-drug interaction between rifampicin and dolutegravir can be overcome by supplemental dolutegravir dosing, which is difficult to implement in high-burden settings. We aimed to test whether virological outcomes with standard-dose dolutegravir-based antiretroviral therapy (ART) are acceptable in people with HIV on rifampicin-based antituberculosis therapy.
methodsRADIANT-TB was a phase 2b, randomised, double-blind, non-comparative, placebo-controlled trial at a single site in Khayelitsha, Cape Town, South Africa. Participants were older than 18 years of age, with plasma HIV-1 RNA greater than 1000 copies per mL, CD4 count greater than 100 cells per μL, ART-naive or first-line ART interrupted, and on rifampicin-based antituberculosis therapy for less than 3 months. By use of permuted block (block size of 6) randomisation, participants were assigned (1:1) to receive either tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50 mg dolutegravir 12 h later or tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus matched placebo 12 h later. Participants received standard antituberculosis therapy (rifampicin, isoniazid, pyrazinamide, and ethambutol for the first 2 months followed by isoniazid and rifampicin for 4 months). The primary outcome was the proportion of participants with virological suppression (HIV-1 RNA <50 copies per mL) at week 24 analysed in the modified intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03851588.
findingsBetween Nov 28, 2019, and July 23, 2021, 108 participants (38 female, median age 35 years [IQR 31-40]) were randomly assigned to supplemental dolutegravir (n=53) or placebo (n=55). Median baseline CD4 count was 188 cells per μL (IQR 145-316) and median HIV-1 RNA was 5·2 log
interpretationOur findings suggest that twice-daily dolutegravir might be unnecessary in people with HIV-associated tuberculosis.
fundingWellcome Trust.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.