Clinical trials: HIV Antibodies
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
Anti-r-HuEpo Associated PRCA Subjects
Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment
Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease.
- Trial name
- NCT01288131
- Testing
- Cyclosporine combine with mycophenolate mofetil, Cyclophosphamide + pred
- Where
- Thailand
- Volunteers
- 8 people
- Sponsor
- Chulalongkorn University
HIV Infections, Pneumococcal Infections
Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children
Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein…
- Trial name
- NCT00099658
- Testing
- Pneumococcal polysaccharide-protein conjugate vaccine
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
HIV-1-infection
Pharmacokinetics and Safety of SAR441236
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).
- Trial name
- NCT03705169
- Testing
- SAR441236
- Where
- 23 sites in United States
- Volunteers
- 52 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Infection, Monoclonal Antibody, Human
Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
Background: VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection.
- Conditions
- HIV Infection, Monoclonal Antibody, Human, HIV Antibodies, VRC01 Monoclonal Antibody
- Trial name
- NCT01993706
- Testing
- VRC-HIVMAB060-00-AB
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Healthy Adult Immune Response
Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults
Background: Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV.
- Trial name
- NCT03565315
- Testing
- VRC-HIVMAB095-00-AB (10E8VLS), VRC-HIVMAB075-00-AB (VRC07-523LS)
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
The purpose of this study is to determine the number of newly formed CD4 cells in children who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4 cells in producing an immune response to…
- Trial name
- NCT00004735
- Testing
- Tetanus toxoid, Hepatitis A Vaccine (Inactivated)
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 81 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Retinitis, HIV Infections
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109.
- Trial name
- NCT00001061
- Testing
- Sevirumab, Foscarnet sodium, Ganciclovir
- Where
- 20 sites in United States
- Volunteers
- 167 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)
The proposed study is a phase 1, open label, single arm study to evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and…
- Trial name
- NCT05245292
- Testing
- 3BNC117-LS, 10-1074-LS, N803
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Rockefeller University
Human Immunodeficiency Virus
3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals
The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at…
- Trial name
- NCT04250636
- Testing
- 3BNC117-LS, 10-1074-LS
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Rockefeller University
HIV Infections, Hepatitis B
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in…
- Conditions
- HIV Infections, Hepatitis B, Measles, Pneumococcal Infections
- Trial name
- NCT00013871
- Testing
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live), Pneumococcal Vaccine, Polyvalent (23-valent)
- Where
- 40 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
HIV Infections
Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART
The purpose of this study was to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in participants with HIV-1 on suppressive combination antiretroviral therapy (cART).
- Trial name
- NCT03787095
- Testing
- Cemiplimab
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Human Immunodeficiency Virus Prevention, Human Immunodeficiency Virus (HIV)
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection.
- Trial name
- NCT03783130
- Testing
- VRC-HIVRGP096-00-VP, Alum Adjuvant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of BG8962 when it is administered by intramuscular…
- Trial name
- NCT00000721
- Testing
- CD4 Antigens
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205.
- Trial name
- NCT00000884
- Testing
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205), ALVAC-RG Rabies Glycoprotein (vCP65)
- Where
- 6 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)