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Antiretroviral Therapy

Study to Evaluate Efficacy and Safety 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 3
Waitlist Available
Research Sponsored by Janssen R&D Ireland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 96 to end of extension (at every 6 months, up to 42 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid \[HIV-1 RNA\] concentrations less than \[\<\] 50 copies per milliliter \[copies/mL\]) HIV-1 infected participants.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 96 to end of extension (at every 6 months, up to 42 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 96 to end of extension (at every 6 months, up to 42 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48
Secondary study objectives
CD4+ Cell Count Post-Week 96 to End of Extension
Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48
Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48
+53 more

Side effects data

From 2020 Phase 3 trial • 1149 Patients • NCT02269917
21%
Upper respiratory tract infection
19%
Nasopharyngitis
14%
Back pain
14%
Diarrhoea
12%
Headache
11%
Arthralgia
10%
Bronchitis
10%
Vitamin D deficiency
10%
Cough
8%
Abdominal pain
8%
Pharyngitis
7%
Fatigue
7%
Influenza
7%
Sinusitis
7%
Syphilis
7%
Pain in extremity
6%
Osteopenia
6%
Hypertension
6%
Gastroenteritis
6%
Oropharyngeal pain
6%
Rash
5%
Nausea
5%
Depression
5%
Vomiting
3%
Pyrexia
2%
Influenza like illness
2%
Gonorrhoea
2%
Rhinitis
2%
Hypercholesterolaemia
2%
Hyperlipidaemia
2%
Musculoskeletal pain
2%
Myalgia
2%
Anogenital warts
2%
Anxiety
2%
Insomnia
2%
Lymphadenopathy
2%
Constipation
2%
Dyspepsia
2%
Vertigo
1%
Diverticulitis
1%
Pneumonia
1%
Vision blurred
1%
Haemorrhoids
1%
Toothache
1%
Chills
1%
Seasonal allergy
1%
Anal chlamydia infection
1%
Fungal infection
1%
Tooth infection
1%
Urinary tract infection
1%
Respiratory tract infection
1%
Pharyngitis streptococcal
1%
Epicondylitis
1%
Urethritis
1%
Viral infection
1%
Procedural pain
1%
Skin abrasion
1%
Blood cholesterol increased
1%
Alanine aminotransferase increased
1%
Blood creatinine increased
1%
Low density lipoprotein increased
1%
Weight decreased
1%
Flank pain
1%
Muscular weakness
1%
Musculoskeletal chest pain
1%
Neck pain
1%
Osteoporosis
1%
Rotator cuff syndrome
1%
Skin papilloma
1%
Dizziness postural
1%
Paraesthesia
1%
Sciatica
1%
Sleep disorder
1%
Dysuria
1%
Haematuria
1%
Proteinuria
1%
Erectile dysfunction
1%
Asthma
1%
Dyspnoea
1%
Nasal congestion
1%
Eczema
1%
Erythema
1%
Hyperhidrosis
1%
Myocardial infarction
1%
Abdominal pain upper
1%
Abdominal distension
1%
Anal pruritus
1%
Flatulence
1%
Aphthous ulcer
1%
Food poisoning
1%
Gastrooesophageal reflux disease
1%
Asthenia
1%
Peripheral swelling
1%
Oedema peripheral
1%
Acute hepatitis C
1%
Chlamydial infection
1%
Cellulitis
1%
Conjunctivitis
1%
Folliculitis
1%
Herpes zoster
1%
Gingivitis
1%
Lower respiratory tract infection
1%
Tooth abscess
1%
Arthropod bite
1%
Contusion
1%
Aspartate aminotransferase increased
1%
Blood creatine phosphokinase increased
1%
Blood pressure increased
1%
Creatinine renal clearance decreased
1%
Weight increased
1%
Decreased appetite
1%
Diabetes mellitus
1%
Muscle spasms
1%
Basal cell carcinoma
1%
Hypoaesthesia
1%
Migraine
1%
Neuropathy peripheral
1%
Abnormal dreams
1%
Productive cough
1%
Rhinitis allergic
1%
Rhinorrhoea
1%
Alopecia
1%
Dermatitis
1%
Dry skin
1%
Night sweats
1%
Seborrhoeic dermatitis
1%
Skin lesion
1%
Acute sinusitis
1%
Limb injury
1%
Ligament sprain
1%
Muscle strain
1%
Hypertriglyceridaemia
1%
Hypophosphataemia
1%
Pruritus
1%
Oral herpes
1%
Onychomycosis
1%
Otitis media
1%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])
Control (Baseline to Switch)
Switch to D/C/F/TAF Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Treatment RegimenExperimental Treatment1 Intervention
Participants will receive a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily, up to Week 48. After Week 48, all participants will continue to receive the D/C/F/TAF tablet in a 48 week extension phase (up to Week 96).
Group II: Current Treatment RegimenActive Control2 Interventions
Participants will receive a boosted protease inhibitor (bPI) (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) up to Week 52. After Week 52, all participants will receive the D/C/F/TAF tablet in a 44 week extension phase (up to Week 96).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D/C/F/TAF
2012
Completed Phase 3
~1310

Find a Location

Who is running the clinical trial?

Janssen R&D IrelandLead Sponsor
31 Previous Clinical Trials
4,562 Total Patients Enrolled
Janssen R&D Ireland Clinical TrialStudy DirectorJanssen R&D Ireland
26 Previous Clinical Trials
3,608 Total Patients Enrolled
~107 spots leftby Dec 2025
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