Clinical Trials in Australia / NCT02881320
Active, not recruiting
Phase 2/3
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
NCT02881320 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
HIV-1 Infection
Investigational drug(s) / intervention(s)
B/F/TAF (Adult Strength) →B/F/TAF (Low Dose) →B/F/TAF (TOS) →B/F/TAF (TOS) →B/F/TAF (TOS) →B/F/TAF (TOS) →
B/F/TAF (Adult Strength): 50/200/25 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (Low Dose): 30/120/15 mg FDC tablets administered orally once daily without regard to food.
B/F/TAF (TOS): 2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.
B/F/TAF (TOS): 2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS): 1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.
B/F/TAF (TOS): 1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily
Study summary
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.
Eligibility
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.
Primary outcome measure(s)
- PK Parameter: AUCtau of Bictegravir — Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. - PK Parameter: Ctau of Bictegravir — Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Ctau is defined as the observed drug concentration at the end of the dosing interval. Cohorts 1 \& 2 Part A will participate in an Intensive PK Evaluation at Week 2 or Week 4. Samples will be collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post-dose. Cohort 3 Part A will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. - PK Parameter: AUC0-24 of TAF (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. - PK Parameter: AUC0-24 of Bictegravir (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. - PK Parameter: Cmax of TAF (Cohort 4) — Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Cmax is defined as maximum observed concentration of drug. Cohort 4 Groups 2, 3, and 4 participants will participate in an Intensive PK evaluation at Week 2. Samples will be collected at 0 (pre-dose) 0.5, 1, 2, 4, and 8 hours post-dose. - Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24 — Up to 24 weeks
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24 — Up to 24 weeks
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's National Health System | Washington D.C. | District of Columbia | |
| Midway Immunology and Research Center | Ft. Pierce | Florida | |
| University of Florida Health | Gainesville | Florida | |
| USF Clinic at Children's Medical Services (study visits and drug storage) | Tampa | Florida | |
| Grady Health System Ponce Center Family and Youth Clinic | Atlanta | Georgia | |
| Wayne Pediatric Clinic | Detroit | Michigan | |
| Bellevue Hospital | New York | New York | |
| Duke Children's Health Center, Pediatric Infectious Diseases | Durham | North Carolina | |
| St. Christopher's Hospital for Children/Section of Immunology | Philadelphia | Pennsylvania | |
| St. Jude Children's Research Hospital | Memphis | Tennessee | |
| Department of Paediatrics and Child Health | Bloemfontein | South Africa | |
| Be Part Ypluntu Centre | Cape Town | South Africa | |
| FAMCRU, Ward J8 | CapeTown | South Africa | |
| Dr. J Fourie Medical Centre | Dundee | South Africa | |
| Enhancing Care Foundation, Durban International Clinical Research Site | Durban | South Africa | |
| Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute | Johannesburg | South Africa | |
| Empilweni Service and Research Unit (ESRU) | Johannesburg | South Africa | |
| VX Pharma(Pty) Ltd | Pretoria | South Africa | |
| Perinatal HIV Research Unit | Soweto | South Africa | |
| The HIV Netherlands Australia Thailand Research Collaboration | Bangkok | Thailand | |
| Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | Thailand | |
| Faculty of Medicine, Khon Kaen University | Khon Kaen | Thailand | |
| Makerere University, Johns Hopkins (MU-JHU) Research Collaboration | Kampala | Uganda | |
| Joint Clinical Research Centre | Kampala | Uganda | |
| Baylor College of Medicine Children's Foundation - Uganda | Kampala | Uganda |
More Gilead Sciences trials in Australia
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Active, not recruiting
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Active, not recruiting
Other trials for the same condition
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Active, not recruiting
Pomalidomide as an Immune-enhancing Agent for the Control of HIV
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02881320 on ClinicalTrials.gov ↗ ← All trials in Australia