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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial
• If ‘other’, further details on the scope of the study:
  To investigate renal fuction in HIV-1 infected treatment naive patients.

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Name of medicine:
  NORVIR

  REYATAZ

  STRIBILD

  TRUVADA
• Medical condition to be studied:
  HIV carrier

Population studied

• Short description of the study population:
  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.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  64

Study design details

• Main study objective:
  To investigate renal function and markers or renal tubular function in HIV-1 infected treatment-naïve patients taking a regimen of STB, a TDF-containing regimen without 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 on renal function, as assessed by markers
• Outcomes:
  To assess glomerular function before and during administration of STB or a regimen containing TDF without COBI as ATV/r plus FTC/TDF or EFV/FTC/TDF compared to a regimen containing neither TDF nor COBI as ATV/r plus ABC/3TC via determination of aGFR using iohexol (a probe GFR marker) plasma clearance and eGFR, To assess tubular function before and during administration of STB, ATV/r plus FTC/TDF, or EFV/FTC/TDF compared to a regimen of ATV/r plus ABC/3TC.To evaluate the pharmacokinetics, antiviral activity, efficacy, safety and tolerability of the three treatment regimens through 24 weeks of treatment.
• Data analysis plan:
  Actual GFR, estimated GFR on each visit will be summarized by treatment group using descriptive statistics. Baseline value for these PD endpoints is defined to be the average of the last two non-missing values before treatment. A parametric analysis of variance (ANOVA) using a mixed-effectsmodel appropriate for this parallel group design will be fitted to thenatural logarithm transferred actual GFR obtained at Weeks 4, 8, 16,and 24. Geometric mean ratios between each test treatment (ie, STB,ATV/r + FTC/TDF, or EFV/FTC/TAF) and reference treatment(ie, ATV/r + ABC/3TC) and 90% confidence intervals will beconstructed.A parametric analysis of variance using a mixed-effects modelappropriate for repeated measurements will be fitted to the naturallogarithm transferred aGFR within each treatment. Geometric meanratios between each post baseline visit and baseline visit and90% confidence intervals will be constructed within eachtreatment group.

Documents

Study results

GS-US-236-0140-Synopsis_f-redact