Clinical trials: Immunodeficiencies
Hereditary Angioedema, HAE
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- APeX-2 (NCT03485911)
- Testing
- BCX7353 capsules
- Where
- 47 sites in United States, Austria and 9 more
- Volunteers
- 121 people
- Sponsor
- BioCryst Pharmaceuticals
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
Human Immunodeficiency Virus (HIV)
Vitamin D3 Supplementation in Patients With HIV: Effects on Interleukin-6 Levels and CD4 Counts
This study aims to evaluate the effect of Vitamin D3 supplementation on inflammatory markers and immune status in patients with HIV who are receiving antiretroviral therapy.
- Trial name
- NCT07553052
- Testing
- Vitamin D3, Antiretroviral (ARV) medications
- Where
- Indonesia
- Volunteers
- 20 people
- Sponsor
- Universitas Sebelas Maret
Healthy
Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with…
- Trial name
- NCT02788045
- Testing
- Ad26.Mos.HIV, Ad26.Mos4.HIV, Clade C gp140
- Where
- 10 sites in United States, Rwanda
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Human Immunodeficiency Virus
3BNC117-LS First-in-Human Phase 1 Study
The proposed study is a phase 1 study of the mAb 3BNC117-LS administered intravenously in HIV uninfected individuals and HIV-infected individuals, and subcutaneously in HIV-uninfected individuals.The objectives of the study are…
- Trial name
- NCT03254277
- Testing
- 3BNC117-LS
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Pre-Exposure Prophylaxis, HIV Infections
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- NCT04712994
- Testing
- PrEP Optimization Interventions
- Where
- 8 sites in Kenya
- Volunteers
- 1,958 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on…
- Trial name
- NCT00389207
- Testing
- nevirapine bid, nevirapine qd, atazanavir
- Where
- 68 sites in Argentina, Germany and 8 more
- Volunteers
- 576 people
- Sponsor
- Boehringer Ingelheim
Human Immunodeficiency Virus
Positive Attitudes Concerning Infant Feeding- a Questionnaire for Women Living With HIV
The PACIFY Study is a questionnaire for antenatal(third trimester) and postnatal(three months post delivery) Human Immunodeficiency Virus (HIV) positive women attending clinics in London and Brighton.
- Trial name
- PACIFY (NCT03294499)
- Testing
- Questionnaire
- Where
- 10 sites in United Kingdom
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Imperial College London
HIV Infections
Anti-HIV Medications for People Recently Infected With HIV
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in…
- Trial name
- NCT00106171
- Testing
- Highly active antiretroviral therapy (HAART)
- Where
- 5 sites in United States, Canada
- Volunteers
- 113 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Nonalcoholic Fatty Liver Disease
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
- Trial name
- SARONAPLUS (NCT05211284)
- Testing
- Saroglitazar Magnesium 4 mg
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Zydus Therapeutics Inc.
HIV Infection, Rotavirus Infection
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries.
- Trial name
- NCT00880698
- Testing
- RotaTeq
- Where
- 6 sites in Botswana, Tanzania and 2 more
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Functional Interval Training for Veterans Exercising Through Telehealth.
Most Veterans living with HIV are 50 years of age or older and can expect to live more than 20 years longer with HIV medication.
- Trial name
- FIT-VET (NCT04103593)
- Testing
- exercise training
- Where
- 3 sites in United States
- Volunteers
- 89 people
- Sponsor
- VA Office of Research and Development
Alcohol Use Disorder, Depression
Zambia Common Elements Treatment Approach Pilot Study
This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and…
- Conditions
- Alcohol Use Disorder, Depression, Post-traumatic Stress Disorder, HIV/AIDS
- Trial name
- ZCAP (NCT03966885)
- Testing
- Brief Intervention, Common Elements Treatment Approach (CETA)
- Where
- Zambia
- Volunteers
- 160 people
- Sponsor
- Columbia University
HIV Infections, HIV-1
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible…
- Trial name
- NCT00980538
- Testing
- Etravirine
- Where
- 29 sites in United States, Argentina and 9 more
- Volunteers
- 180 people
- Sponsor
- Janssen Sciences Ireland UC
Acquired Immunodeficiency Syndrome, HIV Infections
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen…
- Trial name
- NCT01721109
- Testing
- EVG/COBI/FTC/TDF
- Where
- 18 sites in United States, South Africa and 1 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
HIV Infections, Sexually Transmitted Diseases, Viral
mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention
Men who have sex with men (MSM), especially young men who have sex with men (YMSM), and transgender women (TGW) have some of the highest rates of HIV and syphilis diagnoses in the United States.
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Viral, Syphilis
- Trial name
- NCT06059443
- Testing
- mLab App Plus
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
Hereditary Angioedema (HAE)
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with…
- Trial name
- NCT02584959
- Testing
- C1 esterase inhibitor [human] liquid
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 75 people
- Sponsor
- Shire
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