Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02881320
Eligibility Criteria:
Key Inclusion Criteria:
Cohort 1: HIV-1 infected adolescents (12 to \< 18 years of age and screening weight ≥ 35 kg) who are virologically suppressed for ≥ 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to \< 12 years of age and screening weight ≥ 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening.
Cohort 4 Group 1: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to \< 25 kg) who are virologically suppressed for ≥ 6 months prior to screening and unable to swallow tablets.
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the Screening visit. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL (eg, \< 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
* Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
* Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m\^2 according to the Schwartz Formula.
* No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I.
Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to \< 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for ≥ 1 month prior to screening.
* Positive confirmatory HIV test (confirmatory nucleic acid-based testing if \< 18 months of age).
* On a stable ARV regimen for ≥ 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment).
* For \< 1 year of age, eGFR ≥ the minimum normal values for age according to the information below using the Schwartz Formula,
* 30 mL/min/1.73 m\^2 for age \> 4 weeks to ≤ 95 days.
* 39 mL/min/1.73 m\^2 for age ≥ 96 days to ≤ 6 months.
* 49 mL/min/1.73 m\^2 for age \> 6 months to \< 12 months.
* For ≥ 1 year of age, eGFR ≥ 90 mL/min/1.73 m\^2 using the Schwartz Formula.
* No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R.
* For individuals \< 14 kg, M184V/I AND HIV-1 RNA \< 50 copies/mL will be allowed. Individuals with HIV-1 RNA \> 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations.
* Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
17 Years
Study:
NCT02881320
Study Brief:
Protocol Section:
NCT02881320