Development of AntiRetroviral Therapy in Africa (DART) study post hoc safety data analysis comparing safety outcomes of study participants with baseline creatinine clearance of 30-49 mL/min vs participants with creatinine clearance of ≥50 mL/min

Study identification

• EU PAS number:
  EUPAS24473
• Study ID:
  48250
• Official title and acronym:
  Development of AntiRetroviral Therapy in Africa (DART) study post hoc safety data analysis comparing safety outcomes of study participants with baseline creatinine clearance of 30-49 mL/min vs participants with creatinine clearance of ≥50 mL/min
• DARWIN EU® study:
  No
• Study countries:
  Uganda

  Zimbabwe
• Study description:
  This report describes the ViiV Healthcare initiated post-hoc analyses for the 96 week safety outcome comparison of study participants with baseline creatinine clearance (CLcr) of 30-49 mL/min vs participants with CLcr of ≥50 mL/min from the completed open-label interventional Development of AntiRetroviral Therapy in Africa trial (DART), a randomized study where 3316 participants received an antiretroviral therapy regimen containing 150 mg twice daily dose of lamivudine, dosed as a fixed dose combination of lamivudine and zidovudine (COMBIVIR) plus a third antiretroviral drug of either tenofovir, abacavir or nevirapine, the original protocol for the completed DART study has been supplied with results from the ViiV Healthcare post hoc analysis.
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 09/02/2017

Actual: 09/02/2017

Study start date

Planned: 14/02/2017

Actual: 14/02/2017

Date of final study report

Planned: 12/03/2018

Actual: 16/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Regulatory

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