NCT04734652

INSTI's For The Management of HIV-associated TB

A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Centre for the AIDS Programme of Research in South Africa · Network
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm Secondary objectives: To characterize viral suppression rates at weeks 12, 24 and 48 in the standard of care treatment (SOC) arm (currently, TDF 300mg/3TC 300mg/DTG 50mg) and at weeks 12 and 48 in the BIC/FTC/TAF arm. To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin To assess the incidence of TB associated IRIS in each arm, through week 24. To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48. To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48.

Conditions

• HIV/AIDS
• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Biktarvy®	Biktarvy® is a fixed dose combination, single tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration. BIC is an integrase strand transfer inhibitor (INSTI). FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Each tablet contains 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
COMBINATION_PRODUCT	TLD- fixed-drug combination single tablet	Standard of care Dolutegravir-based regimen

Timeline

• Start date: 2022-02-18
• Primary completion: 2024-01-19
• Completion: 2024-08-31
• First posted: 2021-02-02
• Last updated: 2025-10-03
• Results posted: 2025-08-15

Locations

1 site across 1 country: South Africa