New Drug Development
There are 8 studies investigating new drugs, 2 of which are conducted in children. Two studies were completed this year. All of these studies also investigated the pharmacokinetics, safety and efficacy of the new drugs. Two of the studies are conducted in naïve adults and one in experienced adult. One study evaluated the different doses while the other study was done in treatment stable patients. Few patients are required for the pharma studies which have many sites world wide but a much more stringent recruitment/enrollment timeline. HIV-NAT has completed 5 feasibility studies.
From 100 new HIV drugs, this number has been reduced to 60 as of 2012. On August 28, 2012, Stribild or formerly known as the QUAD pill, composed of four drugs (Elvitegravir/cobicisat/emtricitabine/tenofovir) was approved by the US FDA for once a day administration. However, elvitegravir and cobicistat are not approved for use individually and are awaiting US FDA approval at the time this went to press. Cobicistat, like ritonavir, is a pharmacokinetic booster but on its own has no HIV activity whereas elvitegravir is a new integrase inhibitor. Further developments for three new compounds (vicriviroc (a CCR5 inhibitor), GSK-761 (an NNRTI), and bevirimat (a maturation inhibitor)) have been discontinued. Other compounds are currently being investigated in phase 2-3 trials. As there are many compounds, we have picked a few of them that we have found exciting to mention: Rilpivirine (TMC-278), S/GSK1349572, Bevirimat (PA457 or MPC-4326) and Vivecon (MPC 9055). Rilpivirine is a second-generation non-nucleoside reverse transcriptase inhibitor (non-nuke or NNRTI) to be administered once daily with Truvada as a fixed dose combination (FDC) tablet. S/GSK1349572 is a next generation integrase inhibitor that does not need to be administered with a booster. Bevirimat (PA457 or MPC-4326) and Vivecon (MPC 9055) are new drugs from a new class of drugs known as the maturation inhibitor. Many pharmaceutical companies are now developing FDCs which can be administered once daily which will definitely help improve the patients’ adherence and quality of life.
A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a background regimen consisting 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects
A randomized, exploratory, open-label 48-week trial with a 2-week Pre-Treatment Phase to investigate the pharmacokinetics, safety, tolerability and antiviral activity of etravirine (ETR) in combination with ritonavir-boosted atazanavir (ATV/rtv) and 1 NRTI in treatment-experienced HIV-1 infected subjects
This is a multicenter phase 3, randomized, double-blind, active-controlled study to evaluate the safety and efficacy of a regimen containing GS-9350-boosted atazanavir (ATV/GS-9350) versus ritonavir-boosted atazanavir (ATV/r) each administered with emtricitabine/tenofovir disoproxil fumarate (Truvada®, FTC/TDF) in HIV-1 infected, antiretroviral treatment-naïve adult subjects.
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years; Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study (AI424397)
This study will evaluate the pharmacokinetic and efficacy data of atazanavir/r in HIV-infected children.
BMS - AI467003
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate the Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an open-label Period on the Recommended Dose.
An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects, who participated in TMC278 clinical trials.
An open-label, multicenter, multiple-dose pharmacokinetic, safety and efficacy trial of maraviroc in combination with optimized background therapy for the treatment of antiretrovival-experienced CCR-5 tropic HIV-1 infected children 2-<18
A randomised, open label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV 1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART)
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