Clinical trials: Immunodeficiency
HIV Infections
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines.
- Trial name
- NCT02463227
- Testing
- VRC01
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
While HIV prevalence among Men Seeking Men (MSM) in India is 10-15 times higher than in the general population (4.3% vs 0.3%), current interventions for Indian MSM have limited reach.
- Trial name
- NCT04814654
- Testing
- CHALO! 2.0, Attention-matched control (AMC), Digital coupon only (DCO)
- Where
- India
- Volunteers
- 1,004 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human…
- Trial name
- VOYAGE-1 (NCT03222583)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 48 sites in China, Singapore and 1 more
- Volunteers
- 546 people
- Sponsor
- AbbVie
Myeloid Malignancy, Bone Marrow Failure Syndrome
Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation
The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has.
- Conditions
- Myeloid Malignancy, Bone Marrow Failure Syndrome, Transfusion-dependent Red Blood Cell (RBC) Defect, Congenital Immunodeficiency
- Trial name
- NCT01596699
- Testing
- Alemtuzumab, Busulfan, Fludarabine
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of California, San Francisco
Covid-19, Coronavirus Disease 2019
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
The main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in…
- Trial name
- NCT04646044
- Testing
- Bempegaldesleukin, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nektar Therapeutics
Infection, Human Immunodeficiency Virus, HIV Infections
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
- Trial name
- NCT01641809
- Testing
- GSK1265744 10 mg, GSK1265744 30 mg, GSK1265744 60 mg
- Where
- 48 sites in United States, Canada
- Volunteers
- 244 people
- Sponsor
- ViiV Healthcare
HIV Infections
Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV.
- Trial name
- NCT03945981
- Testing
- Dolutegravir + Lamivudine FDC
- Where
- 16 sites in United States
- Volunteers
- 131 people
- Sponsor
- ViiV Healthcare
Neuropathic Pain, HIV Neuropathy
Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in persons living with HIV.
- Conditions
- Neuropathic Pain, HIV Neuropathy, HIV/AIDS, Pain
- Trial name
- NCT03855111
- Testing
- Standard Acupuncture / Moxibustion, Individualized (Tailored) Active Acupuncture / Moxibustion
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- New York University
HIV Infections
A New APPROACH to HIV Testing: Adaptation of POCT for Pharmacies to Reduce Risk and Optimize Access to Care in HIV
An estimated 21% of Canadians with HIV are unaware of their infection. There is a need to improve access to HIV testing to detect infections earlier so individuals can access care early and take steps to prevent transmission to…
- Trial name
- APPROACH (NCT03210701)
- Testing
- A HIV POCT program adapted for & provided by community pharmacists
- Where
- Canada
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Memorial University of Newfoundland
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Hepatitis, Hepatitis C
An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1…
- Conditions
- Hepatitis, Hepatitis C, Hepatitis C/ Human Immunodeficiency Virus Coinfection
- Trial name
- NCT02103439
- Testing
- Algeron, PegIntron
- Where
- 6 sites in Russia
- Volunteers
- 140 people
- Sponsor
- Biocad
HIV Infections
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity).
- Trial name
- NCT01134939
- Where
- 34 sites in Germany
- Volunteers
- 265 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
- Trial name
- INTENSE (NCT00487188)
- Testing
- Enfuvirtide, Highly active antiretroviral treatment (HAART)
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Human Immunodeficiency Virus Type 1
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
- Trial name
- NCT00110305
- Testing
- TMC278 25 mg, TMC278 75 mg, TMC278 150 mg
- Where
- 40 sites in United States, Argentina and 12 more
- Volunteers
- 368 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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 Infection
Comparative Study of Three NNRTI-Sparing HAART Regimens
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen.
- Trial name
- NCT00811954
- Testing
- Emtricitabine/tenofovir disoproxil fumarate, Raltegravir, Darunavir
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 1,814 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
Sexually Transmitted Infections, Human Immunodeficiency Virus
Economic and Social Empowerment To Increase Upwards Mobility Among Women
The proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce…
- Trial name
- ESTIMA (NCT02266108)
- Testing
- ESTIMA Intervention
- Where
- Mexico
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV/AIDS
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
HIV has transformed into a chronic illness due to the advent of effective treatments in the absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs), including lung cancer, has increased three-fold…
- Trial name
- WISE (NCT03289676)
- Testing
- Storytelling Narrative Intervention
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Boston
HIV Infections
The Effectiveness of SMS in Improving Antiretroviral Medication Adherence Among Adolescents Living With HIV in Nigeria
The non-maintenance of ART adherence is a major barrier to the achievement of optimal treatment outcomes among adolescents living with HIV.
- Trial name
- STARTA (NCT03394391)
- Testing
- Daily ART-adherence SMS reminder, Standard Adherence Counselling/Patient experience group chat
- Where
- 5 sites in Nigeria
- Volunteers
- 212 people
- Sponsor
- Dr. Olumide ABIODUN
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