{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T04:57:17Z","timestamp":1777611437828,"version":"3.51.4"},"reference-count":28,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T00:00:00Z","timestamp":1668038400000},"content-version":"unspecified","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"The National Institutes of Health and The South African Medical Research Council","award":["Grant # 1R01AI152142-01"],"award-info":[{"award-number":["Grant # 1R01AI152142-01"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,10,14]]},"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cotreatment of HIV and tuberculosis (TB) reduces morbidity and mortality in coinfected patients. Availability of antiretroviral treatment (ART) drug options, including within drug classes, is important, particularly in high HIV\/TB burden low and middle-income countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a phase 2b, open-label, non-comparative randomised controlled trial to assess the antiretroviral activity of a fixed-drug, single tablet, combination of bictegravir (BIC) 50\u2009mg\/emtricitabine (FTC) 200\u2009mg\/tenofovir alafenamide (TAF) 25\u2009mg (Biktarvy). The primary objective is to determine the efficacy, safety and pharmacokinetics of two times per day, coformulated BIC 50\u2009mg\/FTC 200\u2009mg\/TAF 25\u2009mg in HIV-positive ART-na\u00efve patients with TB who are receiving a rifampicin-based treatment regimen and to characterise viral suppression rates at week 24 through to week 48 in the BIC\/FTC\/TAF arm. We will enrol 120 patients randomised in a 2:1 ratio to the intervention or control arm of the study. A non-comparative contemporaneous control arm in which participants receive a dolutegravir-based regimen (standard of care) will also be enrolled.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) and the South African Health Products Regulatory Authority (SAHPRA) have granted regulatory approval (trial reference numbers: BREC\/00001300\/2020 and SAHPRA 20200810). Trial results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      Clinicaltrials.gov; Trial registration number:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04734652\">NCT04734652<\/jats:ext-link>\n                      ; South African National Clinical Trials Register (SANCTR DOH-27-012021-6789)\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-067765","type":"journal-article","created":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T10:00:53Z","timestamp":1668074453000},"page":"e067765","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-based treatment regimen: a phase 2b open-label randomised controlled trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04734652","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9550-9501","authenticated-orcid":false,"given":"Anushka","family":"Naidoo","sequence":"first","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly E","family":"Dooley","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kogieleum","family":"Naidoo","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"},{"name":"MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nesri","family":"Padayatchi","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"},{"name":"MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nonhlanhla","family":"Yende-Zuma","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rubeshan","family":"Perumal","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"},{"name":"MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gillian","family":"Dorse","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Resha","family":"Boodhram","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuella Chinonso","family":"Osuala","sequence":"additional","affiliation":[{"name":"Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,11,10]]},"reference":[{"key":"2025121514251336000_12.11.e067765.1","unstructured":"UNAIDS . 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