Naive HIV-
Conditions
Interventions
50 mg/300 mg fixed dose combination (FDC) Tablet,
Active Comparator Drug
dolutegravir/lamivudine (DTG/3TC) as a fixed dose combination (FDC)
Sponsors
ViiV Healthcare Company
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected adolescents  2. Weight 40 kg at the time of signing the informed consent form. 3. Screening plasma HIV-1 RNA between 1,000 and ≤500,000 copies per mL. 4. Antiretroviral-naive (defined as no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who received antiretroviral therapy for prevention of mother to child transmission of HIV in the first 3 months of life are allowed. 5. Male or female. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at Screening and negative urine hCG test before Enrollment) and not lactating. 6. The participant's parent(s) or legal guardian or the participant is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.Where applicable, participants must provide written assent.
Exclusion criteria
Exclusion criteria: 1. Females who are breastfeeding or plan to become pregnant or breastfeed during the study. 2. Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 and/or Category C or WHO Stage 3 or 4 disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells per mL or less than 15 percents. 3. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. 4. Unstable liver disease, as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 5. Evidence of HBV infection based on the results of testing at Screening for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (anti-HBs or HBsAb), and HBV DNA as follows: - Participants positive for HBsAg are excluded; - Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. NOTE: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. 6. Anticipated need for any HCV therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period. 7. Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 14 days post completed treatment are eligible. 8. History or sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that in the opinion of the Investigator or Medical Monitor contraindicates participation. 9. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant. 10. Participants who in the investigator’s judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk. 11. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. 12. Treatment with any of the following agents within 28 days of Screening i. radiation therapy, ii. cytotoxic chemotherapeutic agents, iii. any systemic immune suppressant; 13. Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. 14. Receipt of any prohibited mediation and inability or unwillingness to switch to an alternative medication. 15. Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antiviral activity of DTG/3TC week 48 Plasma HIV-1 RNA | — |
Secondary
| Measure | Time frame |
|---|---|
| Antiviral activity of DTG/3TC and extended long term (≥48 weeks) safety ≥48 weeks through 144 weeks Plasma HIV-1 and AEs and laboratory abnormalities | — |
Countries
Thailand
Contacts
Public ContactAnnie Buchanan
ViiV Healthcare
Outcome results
None listed