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Also known as Vitekta®, GS-9137
EVG · 2 trials · 2 indications
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
| Arm | Type | Description |
|---|---|---|
| EVG/COBI/FTC/TDF | EXPERIMENTAL | Participants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country. |
| EVG+RTV | EXPERIMENTAL | EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2. |
| Name | Type | Description |
|---|---|---|
| EVG/COBI/FTC/TDF | DRUG | 150/150/200/300 mg STR administered orally once daily with food |
| EVG | DRUG | Elvitegravir (EVG) tablet administered orally once daily with food |
| RTV | DRUG | Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food |
| ARV regimen | DRUG | The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval). |
Key Inclusion Criteria: * 12 years to \< 18 years of age at baseline * Able to give written assent prior to any screening evaluations * Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements * Plasma HIV-1 RNA levels...
EVG, or elvitegravir, is an investigational small molecule antiviral developed by Gilead Sciences for the treatment of HIV infections and acquired immunodeficiency syndrome. It has been studied in Phase 2 clinical trials, including as part of a fixed-dose combination regimen with cobicistat, emtricitabine, and tenofovir disoproxil fumarate.
EVG is being developed for the treatment of HIV-1 infection and acquired immunodeficiency syndrome. Clinical studies have evaluated it both as a single agent boosted with ritonavir and as part of a single tablet regimen combining elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate in adolescents and adults.
EVG is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the Phase 2 clinical trials of elvitegravir, including studies of the single tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.
EVG is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for the studied HIV indications based on the trials conducted to date. The completed Phase 2 studies enrolled participants in the United States, Puerto Rico, South Africa, and Thailand.
EVG has been studied in two completed Phase 2 trials: NCT01721109, which evaluated the pharmacokinetics, safety, and efficacy of the elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate single tablet regimen in adolescents, and NCT00445146, which assessed the safety of EVG plus ritonavir with other antiretroviral agents in HIV-1 infection.