HIV infections
Conditions
Interventions
One tablet of the fixed-dose combination of Dolutegravir (50 mg) and Lamivudine (300 mg) is administered orally once daily
Or
One tablet of the 3-drug fixed dose combination of Bictegravir (50 mg),
Sponsors
Go Miyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participants with age >=18 years (or older, if required by local regulations) at the time of obtaining informed consent. -An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrollment) and not lactating. -Antiretroviral-naive (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) person living with HIV. -Participant (or participant's legally acceptable representative [LAR]) is capable of giving written informed consent. -Eligible participants or their LAR must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Individuals who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. 2. Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count 35% direct bilirubin). 10. Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment. 11. Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. 12. Signs and symptoms which, in the opinion of the Investigator, are suggestive of active COVID-19 (e.g., fever, cough) infection within 14 days prior to enrollment. 13. Evidence of Hepatitis B virus (HBV) infection based on the results of central lab testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid (DNA) as follows: -Participants positive for HBsAg are excluded; -Participants negative for HBsAb and negative for HBsAg but positive for HBcAb may be excluded based on the following consideration: i. Exclude if HBV DNA is detected [either Upper Limit of Quantification (ULoQ) OR numerical value (ie, between LLoQ and ULoQ)] ii. Not excluded if HBV DNA is negative, not detected 14. Participants with HCV co-infection at Screening are eligible only if: i. liver enzymes meet entry criteria; and ii. HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse DDIs with the study interventions; and iii. HCV disease has undergone appropriate work-up and is not advanced and will not require treatment prior to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percentage of participants with plasma HIV-1 RNA =)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96 -Change from Baseline in HIV-1 RNA (log10 c/mL) and CD4+ cell count and CD4/CD8 ratio over time through Week 24, Week 48 and Week 96. -Occurrence of disease progression (HIVassociated conditions, AIDS and death) through Week 24, Week 48 and Week 96. -Time to virologic suppression (HIV-1 RNA 5% from Baseline at Weeks 48, 24 and 96. -Change in total and regional (trunk and extremities) fat by Dual-energy X-ray absorptiometry (DXA) at Week 48 and Week 96 -Change in total and regional (trunk and extremities) fat-free mass by DXA at Week 48 and Week 96 -Change and percent change from Baseline in lumbar and hip bone mineral density (BMD) and trabecular bone score (TBS) by DXA at Weeks 48 and 96 -Occurrence of metabolic syndrome at Weeks 48 and 96 -Change plasma lipids (total, HDL-, and LDLcholesterol, triglycerides) from Baseline at Week 48 and Week 96 -Change in fasting glucose, insulin, HOMA-IR, HbA1c from Baseline at Week 48 and Week 96 -Change in QDiabetes score and FIB-4 score from Baseline at Week 48 and Week 96 -Change from Baseline in Framingham and DAD(Data collection on Adverse events of anti-HIV Drugs) cardiovascular risk scores at Weeks 48 and 96 -Change from Baseline in systolic and diastolic blood pressure at Week 24, 48 and 96 | — |
Countries
Argentina, Belgium, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Sweden, Switzerland, UK
Contacts
Public ContactMiyuki Go
PPD-SNBL K.K.
Outcome results
None listed