Clinical trials: Optimized Treatment
HIV Infections
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
This study will evaluate T-20 in children.
- Trial name
- NCT00022763
- Testing
- Enfuvirtide
- Where
- 7 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Lymphoblastic Leukemia
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
- Trial name
- NCT01685021
- Testing
- MOR00208 (formerly Xmab5574)
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- MorphoSys AG
Asthma
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control.
- Trial name
- NCT00264849
- Testing
- Omalizumab, Optimized asthma therapy
- Where
- 17 sites in Belgium, Canada and 15 more
- Volunteers
- 406 people
- Sponsor
- Novartis
Depression
African American Knowledge Optimized for Mindfully Healthy Adolescents
The purpose of this study was to better understand how African American families identify and treat emotional and behavioral concerns associated with depression in their adolescent youth.
- Trial name
- AAKOMA (NCT00578318)
- Testing
- Motivational Interviewing Active
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Georgetown University
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Neonatal Anemia
Optimized Erythropoietin (EPO) Treatment
Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared for in the neonatal intensive care unit (NICU).
- Trial name
- OETNA (NCT02075970)
- Testing
- Epoetin Alpha
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of Iowa
HIV Infections
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
- Trial name
- NCT00293267
- Testing
- raltegravir potassium
- Volunteers
- 352 people
- Sponsor
- Merck Sharp & Dohme LLC
Recurrent Glioblastoma, Recurrent Malignant Glioma
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory).
- Conditions
- Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma
- Trial name
- NCT02208362
- Testing
- Arm 1: IL13Ra2-specific CAR Tcm cells, Arm 2: IL13Ra2-specific CAR Tcm cells, Arm 3: IL13Ra2-specific CAR Tcm cells
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- City of Hope Medical Center
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- MOTIVATE 2 (NCT00098722)
- Testing
- Maraviroc (UK-427,857), optimized background therapy
- Where
- 172 sites in United States, Australia and 11 more
- Volunteers
- 474 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents.
- Trial name
- NCT00791700
- Testing
- Maraviroc
- Where
- 41 sites in United States, Brazil and 7 more
- Volunteers
- 103 people
- Sponsor
- ViiV Healthcare
Attention Deficit Hyperactivity Disorder
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting.
- Trial name
- NCT02493777
- Testing
- HLD200 methylphenidate hydrochloride (MPH) Capsules
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- Ironshore Pharmaceuticals and Development, Inc
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- NCT00098748
- Testing
- Optimized Background Therapy (OBT), maraviroc (UK-427,857)
- Where
- 77 sites in United States, Australia and 7 more
- Volunteers
- 190 people
- Sponsor
- ViiV Healthcare
HIV Infections
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus.
- Trial name
- NCT00537394
- Testing
- Enfuvirtide, Raltegravir, Darunavir
- Where
- 64 sites in United States, Puerto Rico
- Volunteers
- 517 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency…
- Trial name
- CAPELLA (NCT04150068)
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Failing ARV Regimen
- Where
- 75 sites in United States, Canada and 9 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
HIV Infections
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.
- Trial name
- PRINCE1 (NCT01099579)
- Testing
- Atazanavir powder, Ritonavir oral solution, Atazanavir capsules
- Where
- 18 sites in Brazil, Chile and 4 more
- Volunteers
- 82 people
- Sponsor
- Bristol-Myers Squibb
HIV, Pediatric
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and…
- Trial name
- NCT01691794
- Testing
- Atazanavir, Ritonavir
- Where
- 27 sites in United States, Argentina and 6 more
- Volunteers
- 108 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- MOTIVATE 1 (NCT00098306)
- Testing
- Maraviroc (UK-427,857), Optimized Background Therapy
- Where
- 22 sites in United States, Canada
- Volunteers
- 601 people
- Sponsor
- ViiV Healthcare
Diabetes Mellitus
Adjunctive Metformin Therapy in Double Diabetes
The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes.
- Trial name
- AMTIDD (NCT01334125)
- Testing
- Metformin
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Massachusetts, Worcester
HIV
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients…
- Trial name
- PRINCE2 (NCT01335698)
- Testing
- Atazanavir Sulphate, Ritonavir
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 160 people
- Sponsor
- Bristol-Myers Squibb