An Evaluation of Weight Gain in Patients Treated with Dolutegravir vs. Other Core Agents (208943)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42173
• EU PAS number:
  EUPAS27523
• Study ID:
  42173
• Official title and acronym:
  An Evaluation of Weight Gain in Patients Treated with Dolutegravir vs. Other Core Agents (208943)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 14/12/2017

Actual: 14/12/2017

Study start date

Planned: 18/01/2019

Actual: 18/01/2019

Data analysis start date

Actual: 01/05/2019

Date of final study report

Planned: 30/08/2019

Actual: 07/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-208943-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable