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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05979311
Other study ID # 219816
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date December 29, 2023
Est. completion date August 24, 2026

Study information

Verified date December 2023
Source ViiV Healthcare
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dolutegravir
Dolutegravir will be administered once daily.
Lamivudine
Lamivudine will be administered once daily.
Bictegravir
Bictegravir will be administered once daily.
Emtricitabine
Emtricitabine will be administered once daily.
Tenofovir alafenamide
Tenofovir alafenamide will be administered once daily.

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Sponsors (1)

Lead Sponsor Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

Argentina,  Belgium,  Denmark,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Japan,  Mexico,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48 Week 48
Secondary Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96 Weeks 24 and 96
Secondary Percentage of participants with HIV-RNA greater than or equal to (>=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96 Weeks 24, 48 and 96
Secondary Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96 Baseline (Day 1) and Weeks 24, 48 and 96
Secondary Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96 Baseline (Day 1) and Weeks 24, 48 and 96
Secondary Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96 Baseline (Day 1) and Weeks 24, 48 and 96
Secondary Number of Participants With HIV-1 Disease Progression Weeks 24, 48 and 96
Secondary Time to virologic suppression (HIV-1 RNA <50 c/mL) from Baseline Baseline (Day 1) and Up to Week 96
Secondary Number of participants with confirmed virologic withdrawal (CVW) Up to Week 96
Secondary Number of Participants with treatment-emergent resistance Up to week 96
Secondary Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96 Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96 Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in bone biomarkers- Serum Bone Specific Alkaline Phosphatase, Serum Procollagen type 1 N- Propeptide, Serum Type I Collagen C-Telopeptides and Serum Osteocalcin at Weeks 48 and 96 (Micrograms per Liter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline (Week 4) in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction status Questionnaire (HIVTSQs) at Weeks 12, 24, 48 and 96 (Scores on a scale) The HIVTSQ status version (HIVTSQs) is assessing participants' satisfaction with their current treatment with a Total score ranging from 0 to 60. Higher scores indicate a greater level of satisfaction with HIV treatment. Baseline is defined as measurement value at Week 4. Baseline (Week 4) and Weeks 12, 24, 48 and 96
Secondary Change from Baseline (Week 4) in Individual Item Scores Using HIVTSQs at Weeks12, 24, 48 and 96 (Scores on a scale) Individual items scores range from 0 to 6 (0=very dissatisfied, 6=very satisfied). Baseline is defined as measurement value at Week 4. Baseline (Week 4) and Weeks 12, 24, 48 and 96
Secondary Change from Baseline (Week 4) in Domains Scores Using HIVTSQs at Weeks 12, 24, 48 and 96 (Scores on a scale) There are two domain scores of General Satisfaction/Clinical and Lifestyle/Ease subscales; each comprised of 5 items with possible scores of 0 to 30. The higher the score, the greater the satisfaction within the subscale. Baseline is defined as measurement value at Week 4. Baseline (Week 4) and Weeks 12, 24, 48 and 96
Secondary Change from Baseline in bothersome symptoms using the Symptom Distress Module at Weeks 4, 12, 24, 48 and 96 (Score on a scale) The Symptom Distress Module (SDM) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom bother score is based on the score for each symptom present ranging from 1 (it does not bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96
Secondary Absolute values for waist and hip circumference (Centimeters) Up to Week 96
Secondary Absolute values for waist to hip ratio and waist to height ratio (Ratio) Up to Week 96
Secondary Absolute values for Body weight (Kilogram) Up to Week 96
Secondary Absolute values for systolic and diastolic blood pressure (millimeters of mercury) Up to Week 96
Secondary Change from Baseline in Body Mass Index (kilogram per square meter) Baseline (Day 1) and Up to Week 96
Secondary Change from Baseline in body weight greater than (>) 5 percentage (%) at Weeks 24, 48 and 96 Baseline (Day 1) and Weeks 24, 48 and 96
Secondary Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96 Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96 Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96 Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in trabecular bone score (TBS) assessed by DXA at Weeks 48 and 96 Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD. Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in fasting glucose (Millimoles per Liter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in insulin (Microunits per millilliter) Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96 Baseline (Day 1), Week 48 and Week 96
Secondary Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c) Baseline (Day 1), Week 48 and Week 96
Secondary Change from Baseline in plasma lipids (total, high-density lipoprotein [HDL], and low-density lipoprotein [LDL] cholesterol, triglycerides) (Millimoles per Liter) at Week 48 and Week 96 Baseline (Day 1), Week 48 and Week 96
Secondary Change from Baseline in QDiabetes Score at Week 48 and Week 96 (Scores on a scale) QDiabetes score defines the risk (percentage) of developing type 2 Diabetes in the next ten years. The score ranges from 0-100. Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in Fibrosis 4 (FIB-4) Score at Week 48 and Week 96 (Scores on a scale) A value of FIB-4 scores below 1.30 is considered as low risk for advanced fibrosis; value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis; and FIB-4 values between 1.30 and 2.67 are considered as intermediate risk of advanced fibrosis. Baseline (Day 1), Weeks 48 and 96
Secondary Number of participants with metabolic syndrome at Weeks 48 and 96 Weeks 48 and 96
Secondary Change from Baseline in Framingham cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale) Coronary heart disease (CHD) risk at 10 years in percent (%) can be calculated with the help of the Framingham Risk Score. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more. Baseline (Day 1), Weeks 48 and 96
Secondary Change from Baseline in Data collection on Adverse events of anti-HIV Drugs (DAD) cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale) Coronary heart disease (CHD) risk at 5 years in percent can be calculated with the help of the DAD Risk Score. The 5-year risk of CHD is classified as low (<1%), moderate (1 to 5%), high (5 to 10%), or very high (>10%). Baseline (Day 1), Weeks 48 and 96
Secondary Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg) Baseline (Day 1), Weeks 48 and 96
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