Study to Evaluate Efficacy, Safety and Tolerability 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 subjects

Phase 1

• Conditions: Human Immunodeficiency Virus Type 1; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003052-31-GB
• Lead Sponsor: Janssen Science Ireland Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

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.
- On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (<) 50 copies per ml (copies/ml) or HIV-1 RNA undetectable by a local HIV-1 RNA test between 12 and 2 months prior to the Screening visit and have HIV-1 RNA <50 copies/ml at the Screening vist
- A single virologic elevation of greater than or equal to (>=) 50 copies per ml after previously reaching viral suppression between 12 and 2 months prior to screening in 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 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1. A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening.
2. Proven or suspected acute hepatitis within 30 days prior to study enter.
3. 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.
4. Hepatitis B surface antigen (HBsAg) positive.
5. Participants with cirrhosis as diagnosed based on local practices.

Study & Design

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