Clinical trials: Immunodeficiency
Acquired Immunodeficiency Syndrome, HIV Infections
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir…
- Trial name
- NCT01565850
- Testing
- D/C/F/TAF, DRV, COBI
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
HIV Infections
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers.
- Trial name
- NCT00376935
- Testing
- Palifermin
- Where
- 22 sites in United States
- Volunteers
- 99 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
Pharmacy-based Pre-exposure Prophylaxis
The proposed research will develop a culturally appropriate pharmacy pre-exposure prophylaxis (PrEP) delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods.
- Trial name
- NCT04393935
- Testing
- Pharmacy Delivered PrEP Intervention
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Infections
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness.
- Trial name
- ENCORE1 (NCT01011413)
- Testing
- Efavirenz 600mg, Efavirenz 400mg
- Where
- Australia
- Volunteers
- 636 people
- Sponsor
- Kirby Institute
HIV/AIDS
Impact of Metformin on Immuno-virologic Parameters in HIV
Non-diabetic, aviremic HIV-infected individuals on antiretroviral therapy (ART) will be randomized to metformin therapy or to observation for 72 weeks.
- Trial name
- NCT04500678
- Testing
- Metformin
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Hawaii
Hereditary Angioedema
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult…
- Trial name
- NCT05259917
- Testing
- KVD900 600 mg, KVD900 300 mg
- Where
- 66 sites in United States, Australia and 19 more
- Volunteers
- 136 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
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
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
Human Immunodeficiency Virus, Treatment
First in Human Study of TLC-ART 101 (ACTU 2001)
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation…
- Conditions
- Human Immunodeficiency Virus, Treatment, Antiretroviral Therapy
- Trial name
- NCT05850728
- Testing
- TLC-ART
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents
The purpose of this study was to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in…
- Trial name
- NCT03332095
- Testing
- Doravirine (DOR), Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF), Antiretroviral (ARV) medications
- Where
- 8 sites in United States, South Africa and 1 more
- Volunteers
- 55 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve…
- Trial name
- NCT04233879
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 95 sites in United States, Argentina and 11 more
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV/AIDS
Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama
The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention.
- Trial name
- NCT03680729
- Testing
- Adapted Brothers Saving Brothers (aBSB), Standard Street Outreach
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Florida State University
Hematologic Disorder
Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)
The goal of this clinical research study is to learn if lenalidomide can increase the level of immunoglobulins (parts of the blood that may help to improve the immune system's function) and/or will improve the protective effect…
- Trial name
- NCT01924169
- Testing
- Lenalidomide, Influenza Vaccine, Pneumovax Vaccine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
HIV Infections
Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response
The purpose of this study is to determine whether the addition of Pyridostigmine to Highly Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant patients in which viral load diminishes, but…
- Trial name
- NCT00518154
- Testing
- Pyridostigmine tablets
- Where
- 2 sites in Mexico
- Volunteers
- 7 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Methamphetamine Abuse
Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use
This study is a single-arm, non-randomized pilot study. Eligible participants are newly enrolled participants in an outpatient methamphetamine treatment program, and study activities will take place contemporaneously with…
- Conditions
- HIV/AIDS, Methamphetamine Abuse, Depression
- Trial name
- NCT03864653
- Testing
- MoodGym
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Friends Research Institute, Inc.
HIV-1
A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to…
- Trial name
- DEFINE (NCT04442737)
- Testing
- D/C/F/TAF FDC, TAF/FTC FDC, INI Based Regimen
- Where
- 34 sites in United States
- Volunteers
- 103 people
- Sponsor
- Janssen Scientific Affairs, LLC
HIV Infections
A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders.
- Trial name
- NCT00145795
- Testing
- Kaletra + Current Dual NRTI Backbone, Current Regimen
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
HIV-1-infection
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate…
- Trial name
- NCT03110380
- Testing
- B/F/TAF, F/TAF, DTG
- Where
- 94 sites in United States, Austria and 4 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
HIV Infections
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
- Trial name
- NCT00364793
- Testing
- Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
- Where
- 17 sites in Argentina, Colombia and 4 more
- Volunteers
- 56 people
- Sponsor
- Bristol-Myers Squibb
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