A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC with Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV type 1 Infected Subjects.

Phase 1

• Conditions: Human Immunodeficiency Virus Type 1; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000754-38-IT
• Lead Sponsor: JANSSEN CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure phophylaxis and pre-exposure phophylaxis); no prior use of
any approved or experimental anti- human immunodeficiency virus
(anti-HIV) drug for any length of time. Subjects treated with postexposure
prophylaxis and/or pre-exposure prophylaxis may be enrolled
in the study if treatment stopped at least 30 days prior to Screening
- Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or
equal to >=1,000 copies per milliliter (copies/mL)
- Cluster of Differentiation 4+ (CD4+) cell count =70 cells/microliter
(cells/mcL)
- Screening HIV-1 genotype report must show full sensitivity to DRV,
TDF and FTC
- Screening eGFRcreatinine >=50 mL/min according to the Cockcroft-
Gault formula for creatinine clearance
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 663
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Subject has been diagnosed with a new acquired immunodeficiency
syndrome (AIDS)-defining condition within the 30 days prior to
screening
- Subject has proven or suspected acute hepatitis within 30 days prior to
screening
- Subject is hepatitis C or hepatitis B positive
- Subject has a history of cirrhosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified