Clinical trials: Immunologic Deficiency Syndrome
Human Immunodeficiency Virus Infection
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral…
- Trial name
- NCT01737359
- Testing
- amdoxovir 300 mg bid, amdoxovir 500 mg bid, tenofovir DF 300 mg qd
- Where
- 6 sites in Argentina
- Volunteers
- 2 people
- Sponsor
- RFS Pharma, LLC
Infection, Human Immunodeficiency Virus
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in…
- Trial name
- NCT01593046
- Testing
- GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection, GSK1265744 LAP 200mg subcutaneous injection
- Where
- 2 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing…
- Trial name
- NCT00933205
- Testing
- Tipranavir
- Where
- 215 sites in Belgium, Brazil and 7 more
- Sponsor
- Boehringer Ingelheim
Immunodeficiency, Skeletal Abnormalities
European Alpha-Mannosidosis Participant
International, multicenter, observational, longitudinal monitoring study to investigate the prevalence of Alpha-Mannosidosis in participants at risk for Alpha-Mannosidosis.
- Conditions
- Immunodeficiency, Skeletal Abnormalities, Deafness, Mental Retardation
- Trial name
- EUMAP (NCT03651245)
- Where
- 19 sites in Germany, Switzerland
- Volunteers
- 667 people
- Sponsor
- CENTOGENE GmbH Rostock
HIV Infections
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved…
- Trial name
- NCT00062660
- Testing
- Tipranavir
- Where
- 146 sites in United States, Australia and 10 more
- Sponsor
- Boehringer Ingelheim
Hepatitis C
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve…
- Trial name
- NCT01467479
- Testing
- Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 185 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hereditary Angioedema
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body
The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air.
- Trial name
- NCT02218294
- Testing
- BCX4161
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
HIV, AIDS
EuroSIDA As An External Comparator To MOTIVATE Trials
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be…
- Trial name
- NCT01329783
- Testing
- maraviroc
- Volunteers
- 1,181 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection
- Trial name
- NCT04003103
- Testing
- Islatravir
- Where
- 9 sites in United States, Israel and 1 more
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections, HSV-2 Genital Herpes
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013…
- Trial name
- NCT00740584
- Testing
- 3% SPL7013 Gel (VivaGel)
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Starpharma Pty Ltd
HIV Infections
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.
- Trial name
- NCT00144287
- Testing
- Tipranavir/Ritonavir
- Where
- 53 sites in Germany
- Volunteers
- 255 people
- Sponsor
- Boehringer Ingelheim
Primary Immunodeficiency Disease
IVIG Boya: Safety, Efficacy, and Pharmacokinetics
The goal of this phase 3, open-label, single-group clinical trial is to assess the efficacy of Boya IVIG in maintaining the mean number of serious bacterial infections to less than one per year in participants with primary…
- Trial name
- BoyaIVIG (NCT06150833)
- Testing
- Boya IVIG
- Volunteers
- 50 people
- Sponsor
- Azidus Brasil
Primary Immunodeficiency
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with…
- Trial name
- NCT02269163
- Testing
- Immune Globulin Intravenous, Prometic's Immune Globulin Intravenous 10%
- Where
- 13 sites in United States
- Volunteers
- 82 people
- Sponsor
- Prometic Biotherapeutics, Inc.
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
HIV Infections
The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS
To determine safety and tolerance of administering aerosolized recombinant interferon gamma (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages by aerosolized IFN-gamma administration.
- Trial name
- NCT00002433
- Testing
- Interferon gamma-1b
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Amgen
HIV Infections
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age).
- Trial name
- NCT00002164
- Testing
- Nelfinavir mesylate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Agouron Pharmaceuticals
HIV Infections
Phase I Trial of S-1153 in Patients With HIV Infection
To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible, of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical pharmacokinetic parameters for S-1153.
- Trial name
- NCT00002214
- Testing
- Capravirine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Lexigen Pharmaceuticals
Non-Hodgkin Lymphoma
Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)
This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed…
- Trial name
- NCT02657447
- Testing
- Betalutin with lilotomab dose 1, Betalutin with lilotomab dose 2
- Where
- Germany
- Sponsor
- Nordic Nanovector
HIV Infections
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and…
- Trial name
- NCT00623597
- Testing
- ritonavir, saquinavir [Invirase]
- Where
- 10 sites in Argentina, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
- Trial name
- NCT00002123
- Testing
- Delavirdine mesylate, Didanosine
- Where
- 84 sites in United States, Puerto Rico
- Sponsor
- Pharmacia and Upjohn
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