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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-000521-40 | Other Identifier | European Medicines Agency |
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The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.
The primary objectives of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF | Experimental | Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent. Participants may switch to B/F/TAF, at a dose based on participant's weight. |
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| Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF | Experimental | Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg. Participants may switch to B/F/TAF at a dose based on participant's weight. |
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| Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF | Experimental | Participants will continue to take the following study drugs they were taking in the parent study:
The dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily. Participants may switch to B/F/TAF at a dose based on participant's weight. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F/TAF (High Dose Tablet) | Drug | 200/25 mg fixed-dose combination (FDC) tablet administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study | Up to 9.5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 9.5 Years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.
Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.
For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.
For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.
Ongoing treatment with or prior use of any prohibited medications.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Salud | Active, not recruiting | Buenos Aires | C1141 ACG | Argentina | ||
| Hospital del Niño |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF) | Experimental | Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant. |
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| F/TAF (Low Dose Tablet) | Drug | 200/10 mg FDC tablet administered orally |
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| F/TAF (Lowest Dose Tablet) | Drug | 120/15 mg FDC tablet administered orally |
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| F/TAF (High Dose TOS) | Drug | 60/7.5 mg tablet for oral suspension (TOS) administered orally |
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| F/TAF (Low Dose TOS) | Drug | 30/3.75 mg TOS administered orally |
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| F/TAF (Lowest Dose TOS) | Drug | 15/1.88 mg TOS administered orally |
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| E/C/F/TAF | Drug | 150/150/200/10 mg tablet administered orally |
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| E/C/F/TAF (Low Dose) | Drug | 90/90/120/6 mg tablet administered orally |
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| Cobicistat (High Dose) | Drug | 150 mg tablet administered orally |
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| Cobicistat (Low Dose) | Drug | 90 mg tablet administered orally |
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| Cobicistat (TOS) | Drug | 30 mg TOS administered orally |
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| B/F/TAF (High Dose) | Drug | 50/200/25 mg FDC tablet administered orally |
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| B/F/TAF (Low Dose) | Drug | 30/120/15 mg FDC tablet administered orally |
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| B/F/TAF (High Dose TOS) | Drug | 15/60/7.52 mg TOS administered orally |
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| B/F/TAF (Low Dose TOS) | Drug | 7.5/30/3.76 mg TOS administered orally |
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| B/F/TAF (Lowest Dose TOS) | Drug | 3.76/15/1.88 mg TOS administered orally |
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| 3rd ARV Agent | Drug | A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country |
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| Nucleos(t)ide reverse transcriptase inhibitors (NRTI) | Drug | NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC) |
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| ATV | Drug | Administered according to the prescribing information |
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| DRV | Drug | Administered according to the prescribing information |
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| Lopinavir Boosted with ritonavir (LPV/r) | Drug | Administered according to the prescribing information |
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| Active, not recruiting |
| Panama City |
| 0816-00383 |
| Panama |
| University of Stellenbosch | Recruiting | Cape Town | 7505 | South Africa |
| Enhancing Care Foundation | Recruiting | Durban | 3629 | South Africa |
| WITS RHI Research Centre | Recruiting | Johannesburg | 2038 | South Africa |
| Rahima Moosa Mother and Child Hospital | Recruiting | Johannesburg | 2112 | South Africa |
| Be Part Yoluntu Centre | Recruiting | Paarl | 7626 | South Africa |
| The Aurun Institute | Recruiting | Pretoria | 0087 | South Africa |
| Perinatal HIV Research Unit | Recruiting | Soweto | 2013 | South Africa |
| Faculty of Medicine - Mahidol University | Active, not recruiting | Bangkok Noi | 10700 | Thailand |
| Khon Kaen University | Active, not recruiting | Khon Kaen | 40002 | Thailand |
| Joint Clinical Research Centre | Recruiting | Kampala | 10005 | Uganda |
| MU-JHU Research Collaboration/MU-JHU Care Ltd | Recruiting | Kampala | 256 | Uganda |
| Baylor College of Medicine | Recruiting | Kampala | Uganda |
| University of Zimbabwe Clinical Research Centre | Recruiting | Harare | Zimbabwe |
| ID | Term |
|---|---|
| D013607 | Tablets |
| C000613801 | emtricitabine tenofovir alafenamide |
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069547 | Cobicistat |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
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