Clinical trials: Immunologic Deficiency Syndromes
Human Immunodeficiency Virus
A Single Dose of Pembrolizumab in HIV-Infected People
Background: Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low CD4+ T-cell count despite taking antiviral medicines that control HIV replication.
- Trial name
- NCT03367754
- Testing
- Pembrolizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing…
- Trial name
- NCT02607956
- Testing
- DTG, F/TAF, B/F/TAF
- Where
- 125 sites in United States, Australia and 9 more
- Volunteers
- 657 people
- Sponsor
- Gilead Sciences
Hereditary Angioedema (HAE)
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema…
- Trial name
- NCT01756157
- Testing
- CINRYZE with rHuPH20
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 47 people
- Sponsor
- Shire
HIV Infections
Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of…
- Trial name
- KALMAR (NCT01068873)
- Testing
- lopinavir/ritonavir plus maraviroc
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Temple University
Hepatitis C, Chronic
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients…
- Trial name
- NCT01399619
- Testing
- PegIFN/RBV, BI201335, BI201335 24W
- Where
- 71 sites in United States, Brazil and 6 more
- Volunteers
- 310 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
This study is to explore the effects of transcutaneous nerve stimulation (TENS) and mindfulness meditation in persons living with HIV (PLHIV) and painful neuropathy in the feet.
- Trial name
- NCT04868123
- Testing
- Transcutaneous Nerve Stimulation (TENS), Mindfulness Meditation
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Rutgers University
HIV/AIDS
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
- Trial name
- NCT04201288
- Testing
- Acceptance-Based Behavior Therapy (ABBT), Enhanced-Treatment-as-Usual (ETAU)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Brown University
IFN-Gamma Therapy, CGD Gene Mutation
Biochemical Response to Interferon-Gamma in Subjects With Specific Gene Mutation in Chronic Granulomatous Disease
Background: Chronic granulomatous disease (CGD) is an immunodeficiency disease in which white blood cells are unable to kill certain bacteria and fungi.
- Conditions
- IFN-Gamma Therapy, CGD Gene Mutation, CGD Response to IFNg, CGD - Chronic Granulomatous Disease
- Trial name
- NCT01147042
- Testing
- IFN-gamma
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
XMEN
Magnesium Supplementation in People With XMEN Syndrome
Background: X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and neoplasia syndrome is called XMEN syndrome. In this genetic condition, the cells have less magnesium than normal.
- Trial name
- NCT02496676
- Testing
- Magnesium L-threonate, Intravenous (IV) magnesium sulfate (MgSO4)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1…
- Trial name
- NCT03188523
- Testing
- MK-8504
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus
Kaletra in Combination With Antiretroviral Agents
The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new…
- Trial name
- PROTEKT (NCT01076179)
- Volunteers
- 502 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
HIV, AIDS
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
- Conditions
- HIV, AIDS, Sleep Disorders
- Trial name
- NCT02477527
- Testing
- Stribild
- Volunteers
- 21 people
- Sponsor
- Midtown Medical Center, Tampa, FL
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
HIV Infections
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1)…
- Trial name
- NCT00105079
- Testing
- saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 44 sites in United States, Canada and 3 more
- Volunteers
- 337 people
- Sponsor
- Hoffmann-La Roche
Human Immunodeficiency Virus
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female…
- Trial name
- NCT00764946
- Testing
- Comparator: raltegravir
- Volunteers
- 209 people
- Sponsor
- Merck Sharp & Dohme LLC
Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV.
- Conditions
- Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
- Trial name
- NCT00099359
- Testing
- Zidovudine, Nevirapine (NVP), Epivir (3TC)
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 1,735 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
HIV Infections
A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
This study will pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to antenatal care in Tanzania and male partners who accompany them.
- Trial name
- Maisha (NCT03600142)
- Testing
- Mashia
- Where
- Tanzania
- Volunteers
- 1,539 people, healthy volunteers welcome
- Sponsor
- University of Utah
Pneumococcal Infections
Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23.
- Trial name
- PNEU-WAY PED (NCT03921424)
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 13 sites in South Africa, Thailand and 1 more
- Volunteers
- 407 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Combination Vaccination Before HIV Treatment Interruption
The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus…
- Trial name
- NCT00212888
- Testing
- Remune and ALVAC
- Where
- 3 sites in Canada
- Volunteers
- 52 people
- Sponsor
- Ottawa Hospital Research Institute