Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age and body weight at screening:
* Cohort 1: ≥ 12 years to \< 18 years weighing ≥ 35 kg.
* Cohort 2: ≥ 6 years to \< 12 years weighing ≥ 25 kg to \< 35 kg.
* Cohort 3: ≥ 2 years to \< 6 years weighing ≥ 10 kg to \< 25 kg.
On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, \> 1 tablet or any other formulation a day).
Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening).
Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
The following laboratory parameters at screening:
* Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula.
* Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase)
≤ 5 x upper limit of normal.
* Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).
You may not be if
CD4 cell count \< 200 cells/mm\^3.
CD4 percentage \< 20%.
Life expectancy ≤ 1 year.
An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening.
Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening.
Acute hepatitis within 30 days prior to screening.
Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed).
Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B virus (HBV) core antibody (antibody against hepatitis B core antigen \[anti-HBc\]) at screening. If a participant is negative for HBsAg and positive for anti-HBc but HBV DNA is undetectable, the participant may be enrolled.
A history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance.
Clareo Health | Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
