Clinical trials: Immunologic Deficiency Syndrome
Hereditary Angioedema
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and…
- Trial name
- NCT01397864
- Testing
- rhC1INH or pdC1INH
- Where
- 17 sites in Bulgaria, Croatia and 11 more
- Volunteers
- 181 people
- Sponsor
- Pharming Technologies B.V.
HIV-1
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants.
- Trial name
- NCT02217904
- Testing
- 1 mg islatravir, 2 mg islatravir, 10 mg islatravir
- Volunteers
- 30 people
- Sponsor
- Merck Sharp & Dohme LLC
Meningitis, Cryptococcal, HIV Infections
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.
- Trial name
- NCT00002306
- Testing
- Fluconazole
- Where
- 14 sites in United States
- Sponsor
- Pfizer
Infection, Human Immunodeficiency Virus
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of…
- Trial name
- NCT01967771
- Testing
- DTG, CBZ
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Primary Immunodeficiency Diseases (PID)
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
The main aim of this study is to determine the impact of digital health technology, such as Alexa Skill, used to support the initiation of home-based subcutaneous immunoglobulin (SCIG) treatment, treatment management, and overall…
- Trial name
- NCT06150534
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Takeda
HIV Infections
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class…
- Trial name
- NCT00326963
- Testing
- Background ARVs, PI, enfuvirtide [Fuzeon]
- Where
- 38 sites in United States, Australia
- Volunteers
- 142 people
- Sponsor
- Hoffmann-La Roche
HIV Infections, Lymphopenia
Safety Study of IL-7 in HIV-infected Patients (Inspire)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T…
- Trial name
- NCT00477321
- Testing
- CYT 107
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 30 people
- Sponsor
- Cytheris SA
Infections, Human Immunodeficiency Virus and Herpesviridae
GSK1349572 Drug Interaction Study With Efavirenz
GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with non-nucleoside HIV reverse transcriptase inhibitors…
- Trial name
- NCT01098526
- Testing
- GSK1349572, Efavirenz
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hereditary Angioedema
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and…
- Trial name
- NCT02448264
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Primary Immunodeficiency (PID)
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.
- Trial name
- NCT02180763
- Testing
- Gammanorm
- Where
- 8 sites in France
- Volunteers
- 31 people
- Sponsor
- Octapharma
HIV Infections
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml.
- Trial name
- NCT00002363
- Testing
- Peptide Construction 3, Synthetic
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Columbia Research Laboratories
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
HIV Infections
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.
- Trial name
- NCT00002383
- Testing
- Saquinavir
- Where
- 10 sites in United States
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Pharmacokinetics, Bioavailability
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Trial name
- NCT00812292
- Testing
- TMC278
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infection
Study of Safety and Pharmacokinetics in Healthy Volunteers and Safety, Tolerability and Antiviral Activity of VM-1500 in Patients With Human Immunodeficiency Virus-1 Infection
A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.
- Trial name
- NCT02485509
- Where
- Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Viriom
Human Immunodeficiency Virus
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)
This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type…
- Trial name
- NCT05494736
- Testing
- MK-8527
- Where
- 4 sites in Romania, South Africa
- Volunteers
- 20 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Meningococcal Disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement…
- Trial name
- NCT02141516
- Testing
- rMenB+OMV
- Where
- 20 sites in Italy, Poland and 3 more
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningitis, Cryptococcal, HIV Infections
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug.
- Trial name
- NCT00002316
- Testing
- Lobradimil, Amphotericin B
- Where
- 11 sites in United States
- Sponsor
- Alkermes, Inc.
HIV Infection
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy.
- Trial name
- NCT00053638
- Testing
- efavirenz, tenofovir, abacavir/lamivudine
- Where
- 58 sites in United States
- Volunteers
- 345 people
- Sponsor
- GlaxoSmithKline
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