NCT04001803 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Czarnogorski M, Garris CP, Dalessandro M, D'Amico R, Nwafor T, Williams W, Merrill D, Wang Y, Stassek L, Wohlfeiler MB, Sinclair GI, Mena LA, Thedinger B, Flamm JA, Benson P, Spreen WR
Perspectives of healthcare providers on implementation of long-acting cabotegravir plus rilpivirine in US healthcare settings from a Hybrid III Implementation-effectiveness study (CUSTOMIZE). J Int AIDS Soc. 2022 Sep;25(9):e26003. doi: 10.1002/jia2.26003.

A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US

Details for clinical trial NCT04001803

Clinical trial NCT04001803 - References