New community recommendations for HIV cure studies that include a treatment interruption
An excellent new community report summarises the safest approaches to research studies that include asking participants to interrupt ART.
Studies that include an analytic treatment interruption (ATI) are usually linked to cure-related research.
The report has been produced by Richard Jefferys at TAG in New York.
It is based on several earlier community initiatives that i-Base was also involved in. It includes results from an activist survey on ATIs and a data review of ongoing studies using an ATI.
Some of the key recommendations include:
- Baseline CD4 count >500 cells/mm3.
- CD4 nadir >350 cells/mm3.
- Screening for cardiovascular risk.
- HBV, HCV and other complications or comorbidities (including diabetes and hypertension) as exclusion criteria.
- Caution in people older than 50 years or in smokers/heavy smokers.
- Restricting maximum time off-ART to 16 weeks (with restart criteria likely to be met earlier than this for many participants).
- Restarting ART if CD4 count drops to <350 cells/mm3 or by 30%.
Jefferys R. Community recommendations for clinical research involving antiretroviral treatment interruptions in adults. TAG. (November 2018)