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Keep this study
Lead
ViiV Healthcare
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
HIV-1-infected adolescents were 12 to \<18 years of age at the time of signing the informed consent form.
Weight was \>25 kg at the time of signing the informed consent form.
Screening plasma HIV-1 RNA was between 1,000 and =500,000 c/mL.
Participants were antiretroviral-naive (defined as having had no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who had received ART for prevention of mother-to-child transmission of HIV in the first 3 months of life were allowed. Participants who had received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) in the past were allowed as long as the last PEP/PrEP dose was = 6 months before HIV diagnosis or there was documented HIV seronegativity at least 2 months after the last prophylactic dose and prior to the date of HIV diagnosis.
Male and female participants were included. A female participant was eligible to participate if she was not pregnant (as confirmed by a negative serum human chorionic gonadotropin \[hCG\] test at Screening and a negative urine hCG test before Enrollment) and not lactating. Female participants of child-bearing potential who were engaging in sexual activity that could have led to pregnancy had to agree to use one birth-control method from 28 days prior to the first dose of study medication until 4 weeks after the last dose of study medication (and completion of the follow-up visit). Condoms were additionally recommended, as appropriate use was the only contraceptive method effective in preventing HIV-1 transmission. The investigator was responsible for ensuring that participants understood how to properly use these contraceptive methods. All participants in the study were also counseled on safer sexual practices, including the use and benefit/risk of effective barrier methods (e.g., male condoms), as well as on the risk of HIV transmission to an uninfected partner.
The participant's parent(s) or legal guardian, or the participant, was capable of giving signed informed consent.
You may not be if
Females who were breastfeeding or who planned to become pregnant or breastfeed during the study were excluded.
Any evidence of active Centers for Disease Control and Prevention (CDC) Stage 3 and/or Category C or World Health Organization (WHO) Stage 4 disease-except cutaneous Kaposi's sarcoma not requiring systemic therapy-and historical or current CD4 cell counts \<200 cells/mm³ or CD4 percent \<15 percent resulted in exclusion.
Participants with severe hepatic impairment (Class C) as determined by the Child-Pugh classification were excluded.
Participants with unstable liver disease (defined by ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones) were excluded.
Evidence of hepatitis B virus (HBV) infection at Screening led to exclusion as follows: participants positive for HBsAg were excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg) and positive for HBV DNA were excluded. Participants positive for anti-HBc (negative HBsAg) and anti-HBs (past and/or current evidence) were immune to HBV and were not excluded.
Participants with an anticipated need for any HCV therapy during the first 48 weeks of the study-and for any HCV therapy based on interferon or drugs with potential adverse drug-drug interactions with study treatment throughout the entire study period-were excluded.
Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) resulted in exclusion. Participants who were at least 24 hours post-completed treatment were eligible.
Participants with a history of sensitivity to any study medication or its components, or to drugs of the same class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicated participation, were excluded.
Participants with ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, resected non-invasive cutaneous squamous cell carcinoma, or cervical, anal, or penile intraepithelial neoplasia were excluded. Other localized malignancies required agreement between the investigator and Study Medical Monitor for inclusion.
Participants who, in the investigator's judgment, posed a significant suicide risk were excluded. A recent history of suicidal behavior and/or suicidal ideation could have been considered evidence of serious suicide risk.
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening resulted in exclusion.
Treatment with radiation therapy, cytotoxic chemotherapeutic agents, or any systemic immune suppressant within 28 days of Screening resulted in exclusion.
Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of the first study dose resulted in exclusion.
Receipt of any prohibited medication, and inability or unwillingness to switch to an alternative medication, resulted in exclusion.
Exposure to an experimental drug or vaccine within 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever was longer) prior to the first study dose resulted in exclusion.
Any evidence of pre-existing viral resistance based on any major resistance-associated mutation in Screening or historical results led to exclusion.
Any verified Grade 4 laboratory abnormality led to exclusion. A single repeat test during Screening was allowed to verify results.
Any acute laboratory abnormality at Screening that, in the Investigator's opinion, would have precluded participation in the study of an investigational compound resulted in exclusion.
ALT \>5× the upper limit of normal (ULN), or ALT \>5× ULN with bilirubin \>1.5× ULN (with \>35 percent direct bilirubin), resulted in exclusion.
Creatinine clearance \<50 mL/min/1.73 m² using the Schwartz equation resulted in exclusion.
Children who were wards of the state or government were excluded.
Clareo Health | Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
