Clinical trials: Immunodeficiency
HIV-1 Infection, HIV Infections
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
- Trial name
- NCT01000818
- Testing
- MK0518 (Raltegravir), famotidine, omeprazole
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV, HIV Infections
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen.
- Conditions
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01967940
- Testing
- TAF, E/C/F/TAF, Current failing ARV regimen
- Where
- 15 sites in United States, Dominican Republic and 3 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency…
- Trial name
- NCT04564547
- Testing
- Islatravir, Ulonivirine, BIC/FTC/TAF
- Where
- 23 sites in United States, France and 1 more
- Volunteers
- 161 people
- Sponsor
- Merck Sharp & Dohme LLC
Hereditary Angioedema
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
- Trial name
- CHANGE 3 (NCT00462709)
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 48 sites in United States
- Volunteers
- 146 people
- Sponsor
- Shire
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Household Contacts
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies.
- Trial name
- NCT04543357
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hereditary Angioedema
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
- Trial name
- NCT01005888
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 16 sites in United States
- Volunteers
- 26 people
- Sponsor
- Shire
Neuropathy
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
- Trial name
- NCT01049217
- Testing
- pregabalin
- Where
- 63 sites in United States, Colombia and 7 more
- Volunteers
- 377 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV Infections
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European…
- Trial name
- NCT03984838
- Testing
- JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
- Trial name
- NCT02010593
- Testing
- Dapivirine Vaginal Ring
- Where
- 3 sites in United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements.
- Trial name
- NCT02478463
- Testing
- Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
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
Infection, Human Immunodeficiency Virus
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC)…
- Trial name
- ASSURE (NCT01102972)
- Testing
- Reyataz + Norvir + Truvada, Reyataz + Epzicom
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 297 people
- Sponsor
- ViiV Healthcare
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
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
- Trial name
- NCT00262080
- Testing
- ecallantide, Phosphate Buffer Saline (PBS),
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Shire
HIV-1 Infection
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically…
- Trial name
- DRIVE-SHIFT (NCT02397096)
- Testing
- Doravirine, Tenofovir, Lamivudine, Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, Baseline regimen of cobicistat-boosted elvitegravir
- Volunteers
- 673 people
- Sponsor
- Merck Sharp & Dohme LLC
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- NCT02586805
- Testing
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 125 people
- Sponsor
- Shire
Herpes Zoster
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly…
- Trial name
- NCT01165203
- Testing
- Herpes Zoster Vaccine GSK1437173A
- Where
- 15 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- GlaxoSmithKline