Clinical trials: Immunologic Deficiency Syndromes
Thrombocytopenia, Hepatitis C
Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection
Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be fatal.
- Conditions
- Thrombocytopenia, Hepatitis C, HIV Infections
- Trial name
- NCT00239733
- Testing
- Anti-D
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.
HIV Infection, Hepatitis B
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus.
- Trial name
- NCT00106964
- Testing
- Engerix-B 20 mcg, Engerix-B 40 mcg, Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
- Where
- 11 sites in United States, Brazil and 1 more
- Volunteers
- 371 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.
- Trial name
- NCT02178800
- Testing
- GSK1265744 Tablets, Injectable GSK1265744
- Where
- 8 sites in United States, Brazil and 2 more
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
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
HIV Infections, Pregnancy Related
PrEP Implementation for Mothers in Antenatal Care
In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at risk receive PrEP while no women not at HIV…
- Trial name
- PrIMA (NCT03070600)
- Testing
- Universal PrEP Counseling, Targeted PrEP Counseling
- Where
- 20 sites in Kenya
- Volunteers
- 4,447 people
- Sponsor
- University of Washington
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
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
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
HIV Infections
Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial
The strategy to support virological suppression on second-line antiretroviral treatment (ART) includes the provision of ART that has a low pill burden, good tolerability, low toxicity, is easily monitored, has a high barrier to…
- Trial name
- ARTIST (NCT03991013)
- Testing
- Dolutegravir 50 mg
- Where
- South Africa
- Volunteers
- 192 people
- Sponsor
- University of Cape Town
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
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01529827
- Testing
- fludarabine phosphate, melphalan, total-body irradiation
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Roswell Park Cancer Institute
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
HIV Infections
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects.
- Trial name
- NCT00752856
- Testing
- Kaletra + Isentress, Atripla
- Where
- 6 sites in United States
- Volunteers
- 51 people
- Sponsor
- University of California, San Diego
Human Immunodeficiency Virus, Depression
Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Many people with HIV infection are not consistently engaged in outpatient HIV care, and avoidance, stigma and denial contribute to poor engagement in HIV care.
- Conditions
- Human Immunodeficiency Virus, Depression, Anxiety
- Trial name
- NCT04481373
- Testing
- THRIVE, Treatment as Usual
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Baylor College of Medicine
Thalassemia, Sickle Cell Disease
Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic blood and marrow transplantation remains the only viable cure for children who suffer from many serious non-malignant hematological diseases. Transplantation, however, carries a high risk of fatal complications.
- Conditions
- Thalassemia, Sickle Cell Disease, Glanzmann Thrombasthenia, Wiskott-Aldrich Syndrome
- Trial name
- NCT01319851
- Testing
- Alefacept
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
HIV Infections
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum …
- Trial name
- Nearly Naive (NCT00442962)
- Testing
- Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate
- Where
- 9 sites in United States, Brazil and 1 more
- Volunteers
- 54 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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