Phase 3
Completed 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
Source: ClinicalTrials.gov NCT03227861 ↗Enrolled (actual)
109
Serious AEs
7.4%
Results posted
Jan 2020
Primary outcomePrimary: 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
◆ Published Evidence
Established
42citations · ~7 / year
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.
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.
Linked Publications (2)
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Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.
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Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.