Antiretroviral Trials

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Not Enrolling, but Ongoing

A Phase III, Randomized, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults (Gemini 2, Protocol: 205543)

Sponsor: Viiv Healthcare

Contact: Adri D’Aquila (416)340-4800 ext. 6723

A Phase III, Randomized, Multicenter, Parallel-group, Open-label Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naïve Adult Participants (FLAIR, Protocol: 201584)

Sponsor: Viiv Healthcare

Contact: Angie Cicci (416)340-4800 ext. 2240

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults (GS-US-380-1490)

Sponsor: Gilead Sciences

Contact: Bryan Boyachuk (416) 340-4239

A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects (TMC114FD2HTX3001)

Sponsor: Janssen Sciences Ireland UC

Contact: Bryan Boyachuk (416) 340-4239

Completed Studies with Results

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults (GS-US-380-1489)

Micronutrient and antioxidant supplementation in persons with untreated HIV infection (CTN 238): The MAINTAIN Study

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults (GS-US-292-0111)

Probiotic VSL#3 for Inflammation and Translocation in HIV Ι (PROOV IT I)

Comparison trial of TMC278 versus
efavirenz (EFV) in the background of emtricitabine and tenofovir (TMC278-TiDP6-C209)

Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients (BI 1100 1486 VERXVE)

Alternative Antiretroviral Strategies: A Comparison of Three Initial Regimens (ALTAIR)

A Multicentre, Randomized, Double-Blind, Comparative Trial of a Novel CCR5 Antagonist, UK-427,857, in combination with Zidovudine/Lamivudine versus Efavirenz in combination with Zidovudine/Lamivudine for the Treatment of Antiretroviral-Naïve HIV-1 Infected Subjects. A4001026

Study of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir When Taken With Truvada in HIV-Infected Treatment Naive Adults (GS-US-216-0114)

Study of Elvitegravir/GS-9350 Versus Atazanavir/Ritonavir When Taken With Truvada in HIV-Infected Treatment Naive Adults (GS-US-236-0103)

A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. GS-US-264-0110

A Multicenter, Randomized, Double Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir +Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naïve HIV Infected Patients With Ccr5 Tropic HIV-1 (MODERN)

A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects (SINGLE, ING114467)

Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals With Herpes Simplex Virus Type 2? (CTN 240)

A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women (ARIA, ING117172)

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With Truvada™, in Treatment-Naïve HIV-1 Infected Subjects (MK-0518-292)

Canadian Cohort of HIV+ Slow Progressors (CTN 247)

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus Truvada Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients (MK-1439-007)

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