Phase 3
N=109
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
HIV-1
Bottom Line
View on ClinicalTrials.gov: NCT03227861 ↗Enrolled (actual)
109
Serious AEs
7.4%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach — 84.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Scientific Affairs, LLC
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach |
84.4 | — |
| SECONDARY Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 |
-1.65; -2.02; -2.43; -2.78; -3.08; -3.14 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 |
81.7 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 |
149.56; 182.11; 222.60 | — |
| SECONDARY Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules |
3 | — |
| SECONDARY Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) |
0.9 | — |
| SECONDARY Percentage of Participants Experiencing Grade 3 and 4 Adverse Events |
11.9; 0.9 | — |
| SECONDARY Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities |
0; 2.8; 0.9; 3.7; 0; 0.9 | — |
| SECONDARY Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings |
— | — |
| SECONDARY Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) |
4.9; 98.0; 0; 2.0; 27.5; 0 | — |
| SECONDARY Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 |
0; 0 | — |
| SECONDARY Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) |
— | — |
| SECONDARY Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment |
3.67 | — |
| SECONDARY Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit |
63.6; 85.7 | — |
| SECONDARY Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 |
83.5; 84.5; 79.4; 76.5; 75.8; 65.6 | — |
| SECONDARY Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 |
99.76; 99.50; 99.02; 98.04; 99.49; 99.48 | — |
| SECONDARY Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 |
56.52; 57.87; 57.88 | — |
| SECONDARY Number of Participants With Hospitalizations |
11 | — |
| SECONDARY Duration of Hospitalizations |
5.0 | — |
| SECONDARY Number of Participants With Outpatient Visits |
33; 28; 16; 6; 0; 25 | — |
| SECONDARY Number of Participants With Emergency Room Visits |
19 | — |
| SECONDARY Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) |
2035.0; 341.0; 212.0; 142.0; 94.0; 66.0 | — |
| SECONDARY Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 |
1.3 | — |
| SECONDARY Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 |
7.5; 2.5 | — |
| SECONDARY Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 |
2.5; 0; 1.3; 0 | — |
| SECONDARY Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 |
10.6; 9.1 | — |
Summary
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test
- Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)
- Must be able to swallow whole tablets
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at screening
Exclusion Criteria
- Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality
- Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC)
- Known history of cirrhosis as diagnosed based on local practices
- Known history of chronic ([>=] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
Data sourced from ClinicalTrials.gov (NCT03227861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.