INSTI's For The Management of HIV-associated TB

Summary

This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving a rifampicin-based tuberculosis (TB) treatment regimen. This study will assess the activity of Bictegravir and dolutegravir-containing ART regimens in patients with drug-susceptible TB through 48 weeks

Timeline

Start

2022-02-18

Primary completion

2024-01-19

Completion

2024-08-31

Publications

• Naidoo A, Naidoo K, Letsoalo MP, Wasmann RE, Dorse G, Perumal R, Moosa MS, Osuala EC, Boodhram R, Chimukangara B, Wiesner L, Israelski D, Denti P, Rooney JF, Dooley KE; INSIGHT Study Team. Fixed-dose combination bictegravir-emtricitabine-tenofovir alafenamide twice-daily for treatment of HIV during rifampicin-based tuberculosis treatment (INSIGHT Study): a phase 2b, open-label, randomised non-comparative trial. Lancet HIV. 2026 Jan;13(1):e9-e20. doi: 10.1016/S2352-3018(25)00200-0. Epub 2025 Dec 1.
• Naidoo A, Dooley KE, Naidoo K, Padayatchi N, Yende-Zuma N, Perumal R, Dorse G, Boodhram R, Osuala EC. 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. BMJ Open. 2022 Nov 10;12(11):e067765. doi: 10.1136/bmjopen-2022-067765.

Drugs

Indications