Clinical trials: HIV Antibodies
HIV Infections
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid…
- Trial name
- NCT01032902
- Testing
- In Vitro Diagnostic Device
- Where
- 5 sites in United States
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Chembio Diagnostic Systems, Inc.
HIV-1 Infection
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases.
- Trial name
- NCT01378156
- Testing
- JS7 plasmid DNA and MVA62B vaccine
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GeoVax, Inc.
Cytomegalovirus Infections, HIV Infections
A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
To determine the safety, tolerance, and potential in vivo antiviral effects of five dosage levels and a dose to be determined of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109; formerly SDZ 89-109) when…
- Trial name
- NCT00002268
- Testing
- Sevirumab
- Where
- 2 sites in United States
- Sponsor
- Sandoz
Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US).
- Trial name
- NCT06368453
- Testing
- INSTI® HIV Self-Test
- Where
- United States
- Volunteers
- 1,728 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV Infections
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and…
- Trial name
- ENTRANCE (NCT07053384)
- Testing
- VH3810109, Fostemsavir (FTR), SOC INSTI-based ART
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 107 people
- Sponsor
- ViiV Healthcare
HIV Infections, HIV Seronegativity
A Study of GENEVAX-HIV, a Possible Vaccine
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug…
- Trial name
- NCT00002232
- Testing
- APL 400-003
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth-Lederle Vaccines
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 Infections
A Study of Anti-HIV Monoclonal Antibody KD-247
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and…
- Trial name
- NCT00917813
- Testing
- KD-247, Physiological saline
- Where
- 15 sites in United States
- Volunteers
- 27 people
- Sponsor
- The Chemo-Sero-Therapeutic Research Institute
COVID-19, COVID-19 Vaccines
COVID-19 Quantitative Antibody Titers & Booster Vaccinations
This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care.
- Conditions
- COVID-19, COVID-19 Vaccines, Immunogenicity, Vaccine
- Trial name
- NCT05104359
- Testing
- Observational
- Where
- United States
- Volunteers
- 825 people
- Sponsor
- Epividian
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
Vaccine Response
Probiotics and Influenza Vaccination Response
Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study.
- Trial name
- VERB (NCT05690373)
- Testing
- Probiotic effect on influenza vaccine response
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Archer-Daniels-Midland Company
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
A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose…
- Trial name
- NCT06652958
- Testing
- VH4527079
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in…
- Trial name
- NCT07682961
- Testing
- Lenacapavir, Lenacapavir Tablet, Teropavimab
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 590 people
- Sponsor
- Gilead Sciences
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.
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
HIV
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.
- Trial name
- NCT02707861
- Testing
- ibalizumab, Optimized Background Regimen
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- TaiMed Biologics Inc.
HIV Infections
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.
- Trial name
- NCT00114699
- Testing
- CCR5mAb004
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Human Genome Sciences Inc.
Human Immunodeficiency Virus (HIV), HIV Infection
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in…
- Conditions
- Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1
- Trial name
- NCT04223804
- Testing
- ABBV-181
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 41 people
- Sponsor
- AbbVie
HIV Infections
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults.
- Trial name
- NCT04871113
- Testing
- GSK3810109A, Dolutegravir+lamivudine SOC regimen
- Where
- 24 sites in United States, Argentina and 4 more
- Volunteers
- 62 people
- Sponsor
- ViiV Healthcare