Clinical trials: Immunologic Deficiency Syndromes
Methamphetamine Abuse, Opioid-use Disorder
Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use (hereafter: meth use) among people with opioid use disorder who are in…
- Conditions
- Methamphetamine Abuse, Opioid-use Disorder, HIV Seropositivity
- Trial name
- STAR-OM (NCT04706624)
- Testing
- Contingency management (12 weeks), Contingency management (6 weeks), SMS reminders
- Where
- 4 sites in Vietnam
- Volunteers
- 667 people
- Sponsor
- Hanoi Medical University
Infections, Papillomavirus, Papillomavirus Vaccines
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected…
- Trial name
- NCT01031069
- Testing
- GSK Biologicals' HPV vaccine 580299, Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
- Where
- 15 sites in Brazil, Estonia and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Positive
Oligonucleotide Ligation Assay (OLA) Resistance Study
The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the…
- Trial name
- OLA (NCT01898754)
- Testing
- Pre-ART Oligonucleotide Assay (OLA)
- Where
- 2 sites in Kenya
- Volunteers
- 991 people
- Sponsor
- University of Washington
HIV Infection
A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and…
- Trial name
- NCT01717287
- Testing
- Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet, Other Anti-Retroviral Therapy
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus, Immune Reconstitution Inflammatory Syndrome
Pediatric Urgent Start of Highly Active Antiretroviral Treatment (HAART)
Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days). This trial will be unblinded.
- Trial name
- PUSH (NCT02063880)
- Testing
- Urgent ART, Early ART
- Where
- 4 sites in Kenya
- Volunteers
- 183 people
- Sponsor
- University of Washington
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Hereditary Angioedema (HAE)
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
- Trial name
- NCT02865720
- Testing
- CINRYZE 500 U, CINRYZE 1000 U
- Where
- 10 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Shire
Hereditary Angioedema
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3.
- Trial name
- NCT00914966
- Testing
- C1 inhibitor (human) [C1 INH]
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01854775
- Testing
- E/C/F/TAF, E/C/F/TAF (Low Dose)
- Where
- 16 sites in United States, South Africa and 3 more
- Volunteers
- 129 people
- Sponsor
- Gilead Sciences
Primary Immunodeficiency
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the…
- Trial name
- NCT04566692
- Testing
- IGSC 20%
- Where
- 12 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
HIV Infections
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each…
- Trial name
- NCT02582983
- Testing
- Enfuvirtide
- Where
- 5 sites in Thailand
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
Sexually Transmitted Infection, Hiv
A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA
Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets.
- Trial name
- IMARA-SA pilot (NCT05504954)
- Testing
- IMARA-SA (intervention group), Health promotion control group
- Where
- South Africa
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Drug-Drug Interaction, HIV Infection
Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Open-label prospective intensive pharmacokinetic study of dihydroartemisinin-piperaquine (DP) in HIV-infected children on efavirenz (EFV)-, lopinavir/ritonavir (LPV/r)-, or dolutegravir (DTG)-based antiretroviral therapy (ART)…
- Trial name
- DPART (NCT04487145)
- Testing
- Dihydroartemisinin-piperaquine
- Where
- 2 sites in Uganda
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Infections, Streptococcal
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
The purposes of this study: To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a…
- Trial name
- NCT00829010
- Testing
- Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib, measles
- Where
- South Africa
- Volunteers
- 489 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV/AIDS
Patient Actor Training to Improve HIV Services for Adolescents in Kenya
The goal of this study is to develop and evaluate a clinical training intervention utilizing standardized patient actors to improve communication and interpersonal skills of health care workers who serve HIV-infected adolescents…
- Trial name
- SPEED (NCT02928900)
- Testing
- Clinician training intervention
- Where
- 6 sites in Kenya
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS, HIV Prevention
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche.
- Trial name
- NCT04686279
- Testing
- Tenofovir Douche
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Adenosine Deaminase Deficiency, Severe Combined Immunodeficiencies (SCID)
Lentiviral (LV) Gene Therapy for Adenosine Deaminase (ADA) Deficiency
This is a historically controlled, non-randomized Phase I/II clinical trial to assess the safety and efficacy of autologous transplantation of CD34+ hematopoietic stem/progenitor cells (HSPCs), obtained from infants affected by…
- Trial name
- NCT01380990
- Testing
- Infusion of autologous EFS-ADA LV CD34+ cells, Haematopoietic Stem Cell Transplantation (HSCT), Busulfan
- Where
- United Kingdom
- Volunteers
- 36 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Severe Combined Immunodeficiency
MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID
Severe combined immune deficiency (SCID) may result from inherited deficiency of the enzyme adenosine deaminase (ADA). Children with ADA-deficient SCID often die from infections in infancy, unless treated with either a bone…
- Trial name
- NCT00794508
- Testing
- ADA gene transfer
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Donald B. Kohn, M.D.
Common Variable Immunodeficiency, Agammaglobulinemia
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period.
- Trial name
- NCT00520494
- Testing
- Vivaglobin
- Where
- 6 sites in Canada, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- CSL Behring