Clinical trials: HIV Antibodies
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04860323
- Testing
- Analytical Treatment Interruption
- Where
- 11 sites in Botswana, Malawi and 2 more
- Volunteers
- 13 people
- Sponsor
- HIV Vaccine Trials Network
HIV Infection, Hepatitis C
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons…
- Trial name
- NCT01285050
- Testing
- Antiretroviral therapy (ART), raltegravir, Emtricitabine and tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
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)
Human Immunodeficiency Virus
Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women
A Phase I Single-Blind randomised trial investigating immunisation strategies using Ad4-EnvCN54, MVA-CN54 and CN54gp140/MPLA combinations in order to maximise antibody responses to Human Immunodeficiency Virus
- Trial name
- Ad4HIV (NCT03408262)
- Testing
- Ad4-EnvCN54, MVA-CN54, CN54gp140/MPLA
- Where
- United Kingdom
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Imperial College London
HIV-1
Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults
Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated.
- Trial name
- NCT02840474
- Testing
- VRC-HIVMAB080-00-AB, VRC-HIVMAB075-00-AB
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Human Immunodeficiency Virus
An Extension of Protocol PRO 140_CD01 Study
This is an extension of Protocol PRO 140_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody)…
- Trial name
- NCT02355184
- Testing
- PRO 140 350mg weekly subcutaneous (SC) injection.
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CytoDyn, Inc.
HIV-1 Infection
Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
Adult participants (18-64 years old) with HIV-1 Infection on ART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study.
- Trial name
- NCT03803605
- Testing
- VRC07-523LS, Vorinostat (VOR)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or…
- Trial name
- NCT04212091
- Testing
- PGT121.414.LS, VRC07-523LS
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
- Trial name
- NCT00865566
- Testing
- DNA plasmid vaccine, Recombinant adenoviral serotype 5 (rAD5) vector vaccine
- Where
- 22 sites in United States
- Volunteers
- 2,504 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it.
- Trial name
- NCT05627258
- Testing
- VRC-HIVMAB0115-00-AB
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).
- Trial name
- NCT05281510
- Testing
- Vesatolimod, VRC07523LS, CAP256V2LS
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Sars-Cov2 Antibodies in Children and Adolescents Living With HIV
European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19
Scientific knowledge about the COVID-19 pandemic and the virus that is causing it (SARS-CoV-2) is developing rapidly, and the investigators have a clearer idea of the population groups who are at higher risk of becoming infected…
- Trial name
- SARS-Cov2 (NCT04726137)
- Where
- 7 sites in Belgium, Greece and 4 more
- Volunteers
- 906 people
- Sponsor
- PENTA Foundation
Relapsed, Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)
This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
- Trial name
- NCT02658968
- Testing
- Betalutin
- Where
- 10 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- Nordic Nanovector
HIV Infections
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV…
- Trial name
- NCT02591420
- Testing
- VRC01, Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
- Where
- 5 sites in Kenya, Tanzania and 2 more
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
- Trial name
- NCT02256631
- Testing
- VRC01, VRC01LS, VRC07-523LS
- Where
- 14 sites in United States, Puerto Rico and 2 more
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04801758
- Testing
- Analytical Treatment Interruption
- Where
- 6 sites in Brazil, Peru
- Volunteers
- 18 people
- Sponsor
- HIV Vaccine Trials Network
HIV
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks.
- Trial name
- TMB-202 (NCT00784147)
- Testing
- Ibalizumab
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 113 people
- Sponsor
- TaiMed Biologics Inc.
HIV/AIDS
Combinatorial Therapy to Induce an HIV Remission
Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission").
- Trial name
- NCT04357821
- Testing
- Combination Intervention
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines