Clinical trials: Immunologic Deficiency Syndrome
Severe Combined Immunodeficiency
Gene Transfer for Severe Combined Immunodeficiency, X-linked (SCID-X1) Using a Self-inactivating (SIN) Gammaretroviral Vector
Researchers are working on ways to treat SCID patients who don't have a matched brother or sister. One of the goals is to avoid the problems that happen with stem cell transplant from parents and unrelated people, such as repeat…
- Trial name
- NCT01129544
- Testing
- Gene transfer
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- David Williams
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
Chronic Pain, Alcohol Use, Unspecified
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of…
- Conditions
- Chronic Pain, Alcohol Use, Unspecified, HIV Infections
- Trial name
- UH3 (NCT04052139)
- Testing
- Low-dose naltrexone, Gabapentin
- Where
- Russia
- Volunteers
- 45 people
- Sponsor
- Boston Medical Center
Kaposi Sarcoma, HIV Infections
An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)
To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept…
- Trial name
- NCT03157167
- Testing
- Tc99m-tilmanocept
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Navidea Biopharmaceuticals
HIV Infection
Traditional Healer-initiated HIV Counseling and Testing in South Africa
The objective of this proposal is to conduct a pilot test of a program aimed at training traditional healers to conduct HIV testing and implementing HIV testing among people living in Bushbuckridge, South Africa.
- Trial name
- NCT05079347
- Testing
- HIV rapid test
- Where
- South Africa
- Volunteers
- 418 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Hereditary Angioedema, Hereditary Angioedema Type I
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE).
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-1 (NCT04618211)
- Testing
- Deucrictibant
- Where
- 36 sites in United States, Bulgaria and 11 more
- Volunteers
- 74 people
- Sponsor
- Pharvaris Netherlands B.V.
Lymphoproliferative Disorders, Autoimmune Lymphoproliferative
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another.
- Conditions
- Lymphoproliferative Disorders, Autoimmune Lymphoproliferative, Primary T-cell Immunodeficiency Disorders, Immune System Diseases
- Trial name
- NCT03663933
- Testing
- e-ATG, Immunosuppression Only Conditioning, Reduced Intensity Conditioning
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Human Immunodeficiency Virus (HIV) Infection
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
- Trial name
- NCT03667547
- Testing
- Raltegravir
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV/AIDS, Smoking Cessation
Learn to Quit-HIV Pilot Study
The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S.
- Conditions
- HIV/AIDS, Smoking Cessation, Tobacco Use Disorder
- Trial name
- NCT04609514
- Testing
- Learn to Quit-HIV, QuitGuide, Nicotine patch
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Duke University
HIV Infections, Contraception
Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa
The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally suppressed, 18-45 years old…
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction
- Trial name
- EPIC (NCT04669678)
- Testing
- Etonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA), Sub-cutaneous medroxyprogesterone acetate (SC MPA)
- Where
- South Africa
- Volunteers
- 110 people
- Sponsor
- University of Alabama at Birmingham
Medication Adherence
China Adherence Through Technology Study
The CATS project is designed to increase understanding of interventions that are feasible and effective in helping injection drug users (IDU) or other patients at high risk of poor medication adherence who are HIV-positive to…
- Trial name
- CATS (NCT01722552)
- Testing
- adherence feedback, standard of care
- Where
- 2 sites in United States, China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Boston University
Human Immunodeficiency Virus
Antiretroviral Improvement Among Medicaid Enrollees
This study will evaluate whether a new program will affect how often human immunodeficiency virus (HIV) antiretroviral therapy (ART) prescriptions are filled and whether the program improves the health of people living with HIV.
- Trial name
- AIMS (NCT05477485)
- Testing
- Experimental: AIMS program - patient, No Intervention/Usual care
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Virginia Commonwealth University
HIV Infection
A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine
The purpose of this study is to compare the body fat distribution in Human Immunodeficiency Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years, an antiretroviral therapy based on efavirenz…
- Trial name
- LYNX (NCT01159743)
- Where
- 26 sites in Spain
- Volunteers
- 346 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Severe Combined Immunodeficiency
MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID
Severe combined immune deficiency (SCID) may result from inherited deficiency of the enzyme adenosine deaminase (ADA). Children with ADA-deficient SCID often die from infections in infancy, unless treated with either a bone…
- Trial name
- NCT00794508
- Testing
- ADA gene transfer
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Donald B. Kohn, M.D.
HIV Antibody Positivity
Feasibility of Positive Links for Youth Care Engagement Intervention
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
- Trial name
- NCT05689515
- Testing
- Mobile health app
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Human Immunodeficiency Virus
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral…
- Trial name
- NCT01734850
- Testing
- Busulfan, Cal-1 modified HSPC, Cal-1 modified CD4+ T lymphocytes
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Calimmune, Inc.
AIDS-Related Plasmablastic Lymphoma, AIDS-Related Primary Effusion Lymphoma
Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy…
- Conditions
- AIDS-Related Plasmablastic Lymphoma, AIDS-Related Primary Effusion Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma, Ann Arbor Stage I Grade 3 Follicular Lymphoma
- Trial name
- NCT01193842
- Testing
- Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide
- Where
- 35 sites in United States
- Volunteers
- 107 people
- Sponsor
- National Cancer Institute (NCI)
HIV Infections
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV.
- Trial name
- NCT05781542
- Testing
- sD-NP-GT8 DNA, IL-12 DNA, Trimer 4571
- Where
- 8 sites in United States, South Africa
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not…
- Trial name
- NCT00955968
- Testing
- Highly active antiretroviral therapy (HAART)
- Where
- 50 sites in United States, Argentina and 7 more
- Volunteers
- 1,653 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infection
Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART
This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) who are…
- Trial name
- NCT01751646
- Testing
- Vitamin D3 50,000 IU
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 214 people
- Sponsor
- University of North Carolina, Chapel Hill
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