The two new clinical trials that THINK is currently preparing for are within the fields of HIV prevention in high-risk groups, and individuals diagnosed with drug sensitive TB.
The HIV prevention trial is sponsored by GILEAD Inc and offers pre-exposure prophylaxis to individuals at high risk of contracting HIV. The trial is being conducted in a number of countries around the world – including Argentina, Brazil, Puerto Rico, Thailand, United States, and South Africa.
At the THINK Hillcrest Clinical Trial Unit (HCTU), men who have sex with men and transgender women will be screened for enrolment into the trial. This randomised control trial has two arms, with one arm allocated to an injectable antiretroviral drug (ART) and the other arm to receive oral ART. Further, HIV incidence will be measured across the entire trial. At the end of the “first phase” of the trial, the safety and efficacy of the injectable (ART) will be compared to the oral ART – and if proven to be safe and effective, all participants will be offered the option of receiving the injectable ART. The HCTU is awaiting final regulatory approvals, and it is envisaged that the trial will open to recruitment this month (September, 2023). For more info, click here.
The second trial is sponsored by TB ALLIANCE and aims to explore the use of a shortened treatment regimen for drug sensItive TB (DSTB). This clinical trial also has a randomised trial study design and aims to assess the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants. The combination of bedaquiline, pretomanid and linezolid is usually offered in combination with other drugs for the treatment of drug resistant TB. In this trial, the combination of these three drugs will be compared to the current standard of care for DSTB. If successful, the regimen could impact on the duration of TB treatment given to this category of patients. The HCTU aims to activate this trial next month (October, 2023), following regulatory approvals. For more info, click here.