A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF or Efavirenz /Emtricitabine/Tenofovir DF) compared to Ritonavir-boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR ≥ 70 mL/min

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24883
• EU PAS number:
  EUPAS8598
• Study ID:
  24883
• Official title and acronym:
  A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF or Efavirenz /Emtricitabine/Tenofovir DF) compared to Ritonavir-boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR ≥ 70 mL/min
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Ireland

  Spain

  United Kingdom
• Study description:
  GS-US-236-0140: The proposed study is to be conducted to fulfill an EU post-approval commitment to investigate renal (kidney) function and markers of renal tubular function in HIV-1 infected treatment-naïve patients taking a regimen of Stribild (STB), a tenofovir (TDF)-containing regimen without cobicistat (COBI), or a regimen without TDF or COBI. The primary objective of the present study is to evaluate the effect of STB or other TDF-containing regimens (atazanavir boosted with ritonavir ATV/r plus Truvada FTC/TDF or Atripla EFV/FTC/TDF) on renal function, as assessed by markers of glomerular filtration rate in HIV-1 infected treatment naïve adults with eGFR ≥ 70 mL/min, compared to ATV/r plus Kivexa (ABC/3TC). Additionally the pharmacokinetics (PK) of COBI, RTV and TFV and selected antiviral drugs in subjects’ regimens will be evaluated.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 29 centres are involved in the study

Networks

UK CRN

Study timelines

Date when funding contract was signed

Planned: 01/04/2014

Actual: 01/04/2014

Study start date

Planned: 15/12/2014

Actual: 15/12/2014

Date of final study report

Planned: 30/09/2016

Actual: 11/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead

Study protocol

Initial protocol

GS-US-236-0140_Protocol Original_28Aug14

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)