Uno studio per fornire accesso continuo al farmaco in studio a bambini e adolescenti che hanno completato studi clinici sui trattamenti anti-HIV di Gilead
Uno studio in aperto, a braccio singolo, per fornire accesso continuo al farmaco in studio ai partecipanti che hanno completato studi clinici pediatrici riguardanti trattamenti anti-HIV di Gilead
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:
- To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.
- To evaluate the safety of the study drug(s) in participants with HIV-1.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Droga: F/TAF (High Dose Tablet)
- Droga: F/TAF (Low Dose Tablet)
- Droga: F/TAF (Lowest Dose Tablet)
- Droga: B/F/TAF (High Dose)
- Droga: B/F/TAF (Low Dose)
- Droga: B/F/TAF (High Dose TOS)
- Droga: 3rd ARV Agent
- Droga: E/C/F/TAF
- Droga: E/C/F/TAF (Low Dose)
- Droga: F/TAF (High Dose TOS)
- Droga: F/TAF (Low Dose TOS)
- Droga: F/TAF (Lowest Dose TOS)
- Droga: Cobicistat (High Dose)
- Droga: Cobicistat (Low Dose)
- Droga: Cobicistat (TOS)
- Droga: B/F/TAF (Low Dose TOS)
- Droga: B/F/TAF (Lowest Dose TOS)
- Droga: Nucleos(t)ide reverse transcriptase inhibitors (NRTI)
- Droga: ATV
- Droga: DRV
- Droga: Lopinavir Boosted with ritonavir (LPV/r)
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Gilead Clinical Study Information Center
- Numero di telefono: 1-833-445-3230 (GILEAD-0)
- Email: GileadClinicalTrials@gilead.com
Luoghi di studio
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Buenos Aires, Argentina, C1141 ACG
- Completato
- Helios Salud
-
-
-
-
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Panama City, Panama, 0816-00383
- Completato
- Hospital del Niño
-
-
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-
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Cape Town, Sud Africa, 7505
- Reclutamento
- University of Stellenbosch
-
Durban, Sud Africa, 3629
- Reclutamento
- Enhancing Care Foundation
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Johannesburg, Sud Africa, 2112
- Reclutamento
- Rahima Moosa Mother and Child Hospital
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Johannesburg, Sud Africa, 2038
- Reclutamento
- WITS RHI Research Centre
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Paarl, Sud Africa, 7626
- Reclutamento
- Be Part Yoluntu Centre
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Pretoria, Sud Africa, 0087
- Reclutamento
- The Aurun Institute
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Soweto, Sud Africa, 2013
- Reclutamento
- Perinatal HIV Research Unit
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-
-
-
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Bangkok Noi, Tailandia, 10700
- Attivo, non reclutante
- Faculty of Medicine - Mahidol University
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Khon Kaen, Tailandia, 40002
- Attivo, non reclutante
- Khon Kaen University
-
-
-
-
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Kampala, Uganda, 10005
- Reclutamento
- Joint Clinical Research Centre
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Kampala, Uganda, 256
- Reclutamento
- MU-JHU Research Collaboration/MU-JHU Care Ltd
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Kampala, Uganda
- Reclutamento
- Baylor College of Medicine
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Kampala, Uganda
- Reclutamento
- Strengthening Institutional Capacity for Research Administration (SICRA)
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Masaka, Uganda
- Reclutamento
- Africa Medical and Behavioral Sciences Organisation
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-
-
-
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Harare, Zimbabwe
- Reclutamento
- University of Zimbabwe Clinical Research Centre
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.
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.
- Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
-
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF
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. |
200/25 mg fixed-dose combination (FDC) tablet administered orally
Altri nomi:
200/10 mg FDC tablet administered orally 120/15 mg FDC tablet administered orally 50/200/25 mg FDC tablet administered orally
Altri nomi:
30/120/15 mg FDC tablet administered orally
Altri nomi:
15/60/7.52 mg TOS administered orally
Altri nomi:
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 |
|
Sperimentale: Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF
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. |
50/200/25 mg FDC tablet administered orally
Altri nomi:
30/120/15 mg FDC tablet administered orally
Altri nomi:
150/150/200/10 mg tablet administered orally
Altri nomi:
90/90/120/6 mg tablet administered orally |
|
Sperimentale: Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF
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. |
200/25 mg fixed-dose combination (FDC) tablet administered orally
Altri nomi:
120/15 mg FDC tablet administered orally 50/200/25 mg FDC tablet administered orally
Altri nomi:
30/120/15 mg FDC tablet administered orally
Altri nomi:
15/60/7.52 mg TOS administered orally
Altri nomi:
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 60/7.5 mg tablet for oral suspension (TOS) administered orally 30/3.75 mg TOS administered orally 15/1.88 mg TOS administered orally 150 mg tablet administered orally
Altri nomi:
90 mg tablet administered orally
Altri nomi:
30 mg TOS administered orally
Altri nomi:
7.5/30/3.76 mg TOS administered orally
Altri nomi:
3.76/15/1.88 mg TOS administered orally
Altri nomi:
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) Administered according to the prescribing information Administered according to the prescribing information Administered according to the prescribing information |
|
Sperimentale: Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)
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. |
50/200/25 mg FDC tablet administered orally
Altri nomi:
30/120/15 mg FDC tablet administered orally
Altri nomi:
15/60/7.52 mg TOS administered orally
Altri nomi:
7.5/30/3.76 mg TOS administered orally
Altri nomi:
3.76/15/1.88 mg TOS administered orally
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study
Lasso di tempo: Up to 2.8 Years
|
Up to 2.8 Years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Percentuale di partecipanti che hanno manifestato eventi avversi emergenti dal trattamento (TEAE)
Lasso di tempo: Fino a 9,5 anni
|
Fino a 9,5 anni
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Gilead Study Director, Gilead Sciences
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Preparati farmaceutici
- Forme di dosaggio
- Tiazoli
- Azoli
- Acidi nucleici, nucleotidi e nucleosidi
- Acidi, aciclici
- Acidi carbossilici
- Purine
- Deossictidina
- Citidina
- Nucleosidi di pirimidina
- Pirimidine
- Composti organofosfori
- Nucleosidi
- Deossiribonucleosidi
- Organofosfonati
- Adenina
- Combinazioni di droga
- Tenofovir
- Emtricitabina
- Carbamati
- Cobicistat
- Elvitegravir, cobicistat, emtricitabina, tenofovir disoproxil fumarato combinazione di farmaci
- Ritonavir
- Compresse
- Bictegravir, emtricitabina, tenofovir alafenamide, combinazione di droghe
- emtricitabine tenofovir alafenamide
Altri numeri di identificazione dello studio
- GS-US-380-6684
- 2024-000521-40 (Altro identificatore: European Medicines Agency)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .