Study to Evaluate Efficacy of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

Phase 1

• Conditions: Human Immunodeficiency Virus Type 1; MedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003052-31-ES
• Lead Sponsor: Janssen R&D, Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-04
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

- Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) only, for at least 6 consecutive months preceding the Screening visit. Participants treated with the combination of DRV + COBI + FTC/TDF and completing the GS-US-216-0130 (NCT01440569) study, and who are fulfilling the present protocol criteria, will be given the option to participate in this study;
- On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (<) 50 copies per milliliter (copies/mL) or HIV-1 RNA undetectable by a local HIV-1 RNA test for at least 6 consecutive months prior to the Screening visit and have HIV-1 RNA <50 copies/mL at the Screening visit;
- A single virologic elevation of greater than or equal to (>=) 50 copies/mL after previously reaching viral suppression within 6 months prior to Screening is acceptable, provided a subsequent test prior to Screening was <50 copies/mL
- Absence of history of failure on DRV treatment and absence of DRV resistance-associated mutations (RAMs), if documented historical genotypes are available
- Normal electrocardiogram (ECG) at Screening (or if abnormal, determined by the Investigator to be not clinically significant)
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- A new acquired immunodeficiency syndrome (AIDS) - defining condition diagnosed within the 30 days prior to Screening
- Proven or suspected acute hepatitis within 30 days prior to study entry
- Hepatitis C antibody positive; however, participants previously cured of hepatitis C virus (HCV) infection, with documented sustained virologic response, that is, undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to participate
- Hepatitis B surface antigen (HBsAg) positive
- Participants with cirrhosis as diagnosed based on local practices. As conventional ultrasound might not allow to adequately rule out liver cirrhosis, the use of other means for specific liver fibrosis staging is preferred

Study & Design

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