Clinical trials: Immunologic Deficiency Syndrome
Angioedema
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).
- Trial name
- NCT00097695
- Testing
- Icatibant
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Shire
HIV/AIDS
PrEP Communication Intervention for Female Clients of a Needle Exchange
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative…
- Trial name
- NCT03541642
- Testing
- Enhanced Intervention, Basic Intervention
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Temple University
HIV-1-infection
Kenya HIV Self-Testing in PrEP Delivery
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
- Trial name
- NCT03593629
- Testing
- 6-month PrEP + blood-based HIV self-test, 6-month PrEP + oral fluid HIV self-test
- Where
- Kenya
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Washington
Human Immunodeficiency Virus Type 1
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered…
- Trial name
- NCT00838162
- Testing
- TMC310911 75 mg twice daily, TMC310911 150 mg twice daily, TMC310911 300 mg twice daily
- Where
- 3 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Human Immunodeficiency Virus (HIV)
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study
PRO 140_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency…
- Trial name
- NCT02990858
- Testing
- PRO 140
- Volunteers
- 43 people
- Sponsor
- CytoDyn, Inc.
HIV/AIDS, Cardiovascular Diseases
Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)
The goal of this research is to generate evidence-based recommendations for the management of cardiovascular disease (CVD) risk in People Living with HIV (PLWH).
- Trial name
- NCT04025125
- Where
- United States
- Volunteers
- 2,039 people
- Sponsor
- Duke University
HIV Infections, Hepatitis C
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV.
- Trial name
- C_ASCENT (NCT02194998)
- Testing
- Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), Dasabuvir (DSV), Ribavirin (RBV)
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 46 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, HIV/AIDS
Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)
The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers)…
- Conditions
- Tuberculosis, HIV/AIDS, Alcohol Abuse
- Trial name
- ADEPTT (NCT03302299)
- Testing
- Isoniazid 300 Mg ORAL TABLET, Pyridoxine 25 Mg Oral Tablet
- Where
- Uganda
- Volunteers
- 302 people
- Sponsor
- University of California, San Francisco
Primary Immunodeficiency Diseases (PID)
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)
- Trial name
- NCT03116347
- Testing
- HYQVIA, KIOVIG, Cuvitru
- Where
- 20 sites in Czechia, Denmark and 6 more
- Volunteers
- 42 people
- Sponsor
- Baxalta now part of Shire
HIV Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Human Immunodeficiency Virus
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved…
- Conditions
- Hepatitis C, Human Immunodeficiency Virus, HIV Infections
- Trial name
- NCT00845676
- Testing
- Pegylated interferon alfa-2a + Ribavirin
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of California, San Francisco
Cervical Cancer, Nonneoplastic Condition
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer. PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well…
- Conditions
- Cervical Cancer, Nonneoplastic Condition, Precancerous Condition
- Trial name
- NCT00667563
- Testing
- quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis, polymerase chain reaction
- Where
- India
- Volunteers
- 150 people
- Sponsor
- AIDS Malignancy Consortium
Primary Immunodeficiency
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined…
- Trial name
- NCT04561115
- Testing
- Gamunex-C, IVIG-PEG
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
HIV, HIV Infections
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01780506
- Testing
- E/C/F/TAF, E/C/F/TDF
- Where
- 117 sites in United States, Australia and 10 more
- Volunteers
- 872 people
- Sponsor
- Gilead Sciences
HIV
Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol) on the human immunodeficiency virus (HIV).
- Trial name
- STATIN (NCT00367458)
- Testing
- Atorvastatin
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mesothelioma, Malignant
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety…
- Trial name
- ARTEMIS (NCT02357147)
- Testing
- Amatuximab, Pemetrexed, Cisplatin
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 124 people
- Sponsor
- Morphotek
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers
The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI)…
- Trial name
- NCT03060447
- Testing
- Vesatolimod, ART
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Gilead Sciences
HIV Infections, Sexually Transmitted Diseases
Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.
- Trial name
- NCT00339040
- Testing
- Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immune Deficiency Disorder
Primary Immunodeficiency in Kuwait
Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity.
- Trial name
- NCT03618147
- Where
- Kuwait
- Volunteers
- 314 people
- Sponsor
- Kuwait Society for Allergy and Clinical Immunology
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