Scaling up optimized second-line combination antiretroviral therapy for HIV patients who have failed first-line treatment.
There is a growing need for a more compact and simple regimen for use in second-line therapy for people with HIV in resource-limited settings.
This will become increasingly critical as a larger number of people living with HIV encounter drug resistance and treatment failure. These patients will need access to second-line therapy.
The project will gather critical evidence to support the development of guidelines on the use of improved second-line regimens such as a dolutegravir+ darunavir/r combination. It is currently being implemented in up to 9 countries across Africa, Asia and Latin America.
“Current recommendations for second-line treatment regimens are suboptimal in resource-limited settings, where the vast majority of people with HIV live. This trial is exploring whether an alternative regimen of treatment is clinically superior or equal to the currently recommended treatments. Results have the potential to impact the treatment of millions of people living with HIV”
David Cooper, Trial Principal Investigator
Progress so far
The grant agreement was signed in December 2016 and is in its early stages of inception.
The impact we are seeking
The direct impact of the clinical trial will be to increase the evidence base for second-line combination antiretroviral therapy, working from a hypothesis that the dolutegravir and boosted darunavir regimen is not inferior to the standard of care. The results will assist public health agencies in identifying the optimal approach to providing second-line combination antiretroviral therapy in low- and lower-middle income countries.
Over the long-term, the grant could offer a pathway for a second-line regimen that is easier to take; a one-pill, once-daily regimen, which has fewer side effects and is more durable to drug resistance.