Clinical trials: Deficiency Disease
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
HIV Infections
Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals
Clinical specimens are required from HIV positive individuals with viremia controlled by antiretroviral therapy to complete process development for a genetically modified autologous T cell product, AGT103-T.
- Trial name
- NCT03215004
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- American Gene Technologies International Inc.
Acquired Immunodeficiency Syndrome, HIV Infections
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen…
- Trial name
- NCT01721109
- Testing
- EVG/COBI/FTC/TDF
- Where
- 18 sites in United States, South Africa and 1 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
HIV Infections
PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.
The purpose of the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single oral doses of TMC589337 and…
- Trial name
- NCT00908414
- Testing
- TMC589337 40 mg, TMC589337 100 mg, TMC589337 200 mg
- Where
- Netherlands
- Volunteers
- healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Herpes Simplex, HIV Infections
A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients.
- Trial name
- NCT00002116
- Testing
- Cidofovir
- Where
- 9 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Malaria in Pregnancy, HIV Infection
Efficacy of Antifolates Against Malaria in HIV-infected Pregnant Women and the Emergence of Induced Resistance in Plasmodium Falciparum
Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to…
- Trial name
- MACOMBA (NCT01746199)
- Testing
- cotrimoxazole daily prophylaxis, sulphadoxine-pyrimethamine
- Where
- 4 sites in Central African Republic
- Volunteers
- 193 people
- Sponsor
- Institut Pasteur
HIV-infection
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach.
- Trial name
- NCT02489487
- Testing
- VM-1500, Darunavir, Ritonavir
- Where
- Thailand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viriom
Infection, Human Immunodeficiency Virus
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV.
- Trial name
- NCT00296504
- Testing
- fosamprenavir (GW433908), ritonavir
- Where
- 24 sites in United States, Brazil and 6 more
- Volunteers
- 753 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA…
- Trial name
- NCT02120352
- Testing
- CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 309 people
- Sponsor
- ViiV Healthcare
Primary Immune Deficiency
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy.
- Trial name
- NCT00680446
- Testing
- Immunoglobulin G (Ig NextGen 16%)
- Where
- 9 sites in Australia, New Zealand
- Volunteers
- 41 people
- Sponsor
- CSL Limited
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
HIV Infections
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
- Trial name
- NCT00002194
- Testing
- Erythromycin, Nevirapine, Clarithromycin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Alpha 1 Antitrypsin Deficiency
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
- Trial name
- SWIFT-SC (NCT07555483)
- Testing
- Alpha-1 15%, Liquid Alpha1-PI
- Where
- 22 sites in United States, Denmark and 7 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Common Variable Immunodeficiency (CVID), APDS / PASLI
Study of Efficacy of CDZ173 in Patients With APDS/PASLI
This study was designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with genetically activated PI3Kδ, i.e., patients with Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing…
- Trial name
- NCT02435173
- Testing
- CDZ173
- Where
- 10 sites in United States, Belarus and 7 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Long Chain Fatty Acid Oxidation Disorders
Expanded Access to Triheptanoin
Expanded access may be provided for qualified patients who have limited treatment options and are not eligible for a clinical trial.
- Trial name
- NCT03773770
- Testing
- Triheptanoin
- Sponsor
- Ultragenyx Pharmaceutical Inc
HIV Infections
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in…
- Trial name
- NCT07682961
- Testing
- Lenacapavir, Lenacapavir Tablet, Teropavimab
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 590 people
- Sponsor
- Gilead Sciences
Hereditary Angioedema
A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema
This study is about teenagers and adults with hereditary angioedema (HAE) type I and type II. In this study, the burden of illness means the impact of HAE in terms of long-term health outcomes and the financial cost.
- Trial name
- BOISTERN (NCT04957641)
- Where
- 36 sites in Austria, Belgium and 20 more
- Volunteers
- 221 people
- Sponsor
- Takeda
HIV Infections
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ).
- Trial name
- NCT00002094
- Testing
- Atevirdine mesylate
- Where
- United States
- Sponsor
- Pharmacia and Upjohn
Adult Growth Hormone Deficiency, Growth Hormone Disorder
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered…
- Trial name
- REAL 2 (NCT02382939)
- Testing
- somapacitan, somatropin
- Where
- 28 sites in Denmark, France and 4 more
- Volunteers
- 92 people
- Sponsor
- Novo Nordisk A/S
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