PHARMACEUTICAL TRIALS
Completed Trials:
Triangle Pharmacy MKC- 442
An open – labeled study of MKC – 442 in combination with nucleoside reverse transcriptase inhibitors in HIV-1 infected pediatric patients to evaluate its pharmacokinetics, preliminary safety and antiviral efficacy.
Duration: January 1999 – 2001
Boehringer Ingelheim BI Trial No 1100-1368
A randomized open-labeled multi-centre trial the pharmacokinetics, efficacy and safety of parameters of Nevirapine 4 or 7mg when administered in combination with ZDV and 3TC for 8 weeks in anti- retroviral naïve pediatric patients.
Duration: Feb 2002 to Dec 2004
TMC114 – C212
A phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC/RTV b.i.d in treatment-experienced HIV-1 infected children and adolescents.
Duration: Sep. 2006 – April 2010
Secure the future: 6 versus 9 months
Randomized clinical trial to evaluate the optimal duration of TB chemotherapy in Human Immunodeficiency Virus infected in children with TB and to assess the effect of TB on the natural history of Human Immunodeficiency Virus infection
Duration: November 2002 – January 2006
Stavudine Adult Bioequivalence study
Randomized cross- over pharmacokinetic study to compare the bioavailability of opened vs. intact generic stavudine capsules
Duration: 26 July 2008 – 16 August 2008
MSD
A Multicenter, randomized, double – blind, double – dummy, parallel – group study evaluating the effects of 2 different regiments of Montelukast (Daily dosing and intermittent, episode driven dosing) compared with placebo in the treatment of episodic asthma in children aged 2 to 5 years.
Duration: March 2006 to March 2007
Boehringer Ingelheim Extended dose nevirapine
This study is looking at a formulation of nevirapine that only needs to be given once a day instead of twice as presently used. The correct dose, safety and efficacy of extended release nevirapine will be determined.
Inclusion age criteria: ≥ 3 to ≤ 18 years
Duration May 2009 – December 2009
Current Trials:
APV 20002
A 48 Week Phase II, Open-label, 2 cohort, Multi-centre study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of GW433908 andGW433908/RTV when administered to HIV-1 infected Protease Inhibitor (PI) Naïve and PI – experienced pediatric subjects aged 4weeks to < 2 years.
Duration: 17 March 2008 – ongoing
APV 29005
A 48 week, Phase II, Non-Comparative, Open – Label, Multi-Cohort, multi-center Study to evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID when administered to HIV-1 infected, PI-naïve and experienced. Pediatric subjects 2 to <6 years old.
Duration: 19 August – ongoing
BMS
An Open-Label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination with Didanosine and Emtricitabine in HIV-Infected Infants and Children 3 months to 6 years of Age.
Duration: 01 July 2010 - ongoing
BMS Prince I
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 Optimal 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)
Duration: 1February 2011 - ongoing
BMS – Prince II
A Prospective Single Arm, Open-label, International, Multicentre 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, Antiretroviral, Naive and Experienced Pedriatric Subjects Greater Than or Equal to 3 Months to Less Than 8 Years (Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study)
Duration: 1 November 2011 – ongoing
Trials Coming soon:
Gilead (QUAD) Study
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen(STR) in HIV- Infected Antiretroviral Treatment-Naive Adolescents Treatment-Naive Adolescents
BMS Prince III
Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years
