Clinical trials: Deficiency Disease
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Hepatic Porphyria, Acute Intermittent Porphyria
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).
- Conditions
- Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria
- Trial name
- NCT03338816
- Testing
- Givosiran
- Where
- 36 sites in United States, Australia and 16 more
- Volunteers
- 94 people
- Sponsor
- Alnylam Pharmaceuticals
X-linked Hypophosphatemia
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).
- Trial name
- NCT02537431
- Testing
- burosumab
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin, Inc.
Ejaculatory Dysfunction, Hypogonadism
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.
- Trial name
- NCT01419236
- Testing
- Testosterone Solution 2%
- Where
- 7 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Eli Lilly and Company
Hepatitis C, Chronic, HIV Infection
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.
- Trial name
- NCT01147107
- Testing
- Raltegravir, Efavirenz
- Where
- 2 sites in Vietnam
- Volunteers
- 80 people
- Sponsor
- University of Hawaii
HIV Infections
Clinical Trial of CNS-targeted HAART (CIT2)
CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI).
- Trial name
- NCT00624195
- Testing
- FDA Approved Antiretroviral Therapy (see list below)
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of California, San Diego
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen
The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to…
- Trial name
- NCT02478632
- Testing
- Subjects do not receive study medication in this study 202094
- Where
- 32 sites in United States, Argentina and 4 more
- Volunteers
- 102 people
- Sponsor
- ViiV Healthcare
HIV Infections, Kidney Diseases
Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.
- Trial name
- NCT02741323
- Testing
- Maraviroc
- Where
- 10 sites in United States
- Volunteers
- 97 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Substance Use Disorders
HIV+ Substance Users Released From Jail
The long-term goal of this project is to improve HIV and substance use outcomes and reduce recidivism for HIV+ substance users released from jail.
- Trial name
- NCT03834779
- Testing
- DOORS-CHW Intervention
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Texas Southwestern Medical Center
ADA-SCID, Adenosine Deaminase Deficiency
EZN-2279 in Patients With ADA-SCID
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated with Adagen.
- Conditions
- ADA-SCID, Adenosine Deaminase Deficiency, Severe Combined Immunodeficiency
- Trial name
- NCT01420627
- Testing
- EZN-2279, Adagen
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Leadiant Biosciences, Inc.
Hypogonadism, Male, Physical Activity
Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular…
- Conditions
- Hypogonadism, Male, Physical Activity, Testosterone Deficiency
- Trial name
- NCT03282682
- Testing
- Strength training
- Where
- Slovakia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Comenius University
HIV/AIDS, Sexually Transmitted Diseases
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and…
- Trial name
- STAR (NCT04121962)
- Testing
- Peer Mentor, Website only
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
AIDS, HIV Infections
CSP #512 - Options in Management With Anti-Retrovirals
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs.
- Trial name
- OPTIMA (NCT00050089)
- Testing
- No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP, Standard ART vs Mega ART
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 368 people
- Sponsor
- US Department of Veterans Affairs
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes
Almost all people who have had type 1 diabetes for 5 years have a defect in secretion of the hormone Glucagon. This hormone is involved in the body's response to low blood glucose (hypoglycaemia).
- Conditions
- Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia, Hypoglycemia, Hypoglycemia Unawareness
- Trial name
- NCT04614168
- Testing
- Stepped hyperinsulinaemic-hypoglycaemic clamp study, Insulin pump, Continuous glucose monitor
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- University of Edinburgh
Acquired Immunodeficiency Syndrome, HIV Infections
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus…
- Trial name
- NCT01533259
- Testing
- Stribild
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Anemia, Iron-Deficiency
The Benefits of a Preoperative Anemia Management Program
The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneous doses of a drug given…
- Trial name
- PAMP (NCT01888003)
- Testing
- Iron sucrose, Epoetin Alfa, Blood Transfusion
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Alabama at Birmingham
Human Immunodeficiency Virus Type 1 (HIV-1)
A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants
This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the…
- Trial name
- NCT05896761
- Testing
- Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
- Where
- 32 sites in United States, Argentina and 5 more
- Volunteers
- 118 people
- Sponsor
- ViiV Healthcare
Primary Immunodeficiency
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01…
- Trial name
- NCT03907241
- Testing
- Octanorm 16.5%
- Where
- 7 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Octapharma
Primary Immune Deficiency Diseases (PIDD)
Study of PlasmaCap IG in Adults and Children With PIDD
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares…
- Trial name
- NCT03238079
- Testing
- 10% IGIV
- Where
- 12 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Evolve Biologics