Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial.
Lancet HIV
; 8(11): e723-e728, 2021 11.
Article
in English
| MEDLINE | ID: covidwho-1373322
ABSTRACT
Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. This Viewpoint describes how we managed ethical issues over the duration of one of these trials (HPTN 083). Specifically, we discuss the rationale for pursuing a long-acting injectable agent in the presence of effective oral PrEP, trial design choices, site selection and local standards of prevention, data monitoring and early stopping, effects of the COVID-19 pandemic, post-trial access, and assessment of long-term safety.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
HIV Infections
/
Anti-HIV Agents
/
Pre-Exposure Prophylaxis
/
COVID-19
Type of study:
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Lancet HIV
Year:
2021
Document Type:
Article
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