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Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults

NCT02246998 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-01-03

Study results available
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Summary

The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

Conditions

  • HIV-1 Infection

Interventions

DRUG

STB

150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food

DRUG

TVD

200/300 mg FDC tablet administered orally once daily with food

DRUG

ATR

600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime

DRUG

RTV

100 mg tablet administered orally once daily with food

DRUG

ATV

300 mg capsule administered orally once daily with food

DRUG

ABC/3TC

600/300 mg FDC tablet administered orally once daily with food

DRUG

Iohexol

1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-15
Primary Completion
2016-01-20
Completion
2016-02-17
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Ireland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246998 on ClinicalTrials.gov