What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, including antiretroviral therapies and monoclonal antibodies like VRC01.23LS, can have various side effects. Antiretroviral drugs often cause mild to moderate side effects such as headache, fatigue, and gastrointestinal issues like diarrhea. Severe side effects can include liver toxicity, hypersensitivity reactions, and central nervous system effects. Monoclonal antibodies, while generally well-tolerated, may cause infusion-related reactions, including fever, chills, and rash. Monitoring and managing these side effects are crucial for the effective long-term treatment of HIV/AIDS.

What prior FDA approvals exist?

The FDA has approved several treatments for HIV/AIDS, primarily focusing on antiretroviral therapies (ART) that inhibit various stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. While VRC01.23LS is an antibody that blocks HIV-like viruses, similar antibody-based treatments, such as ibalizumab-uiyk, have been approved. Ibalizumab-uiyk is a monoclonal antibody that binds to the CD4 receptor on T-cells, preventing HIV from entering the cells. This represents a newer class of treatments aimed at providing additional options for patients with multidrug-resistant HIV.

What other types of research exist?

Promising alternatives to VRC01.23LS for HIV/AIDS treatment in 2024 include: 1) Broadly neutralizing antibodies (bNAbs) like 3BNC117 and 10-1074, which have shown potential in clinical trials. 2) Long-acting injectable antiretrovirals such as cabotegravir and rilpivirine, which offer extended dosing intervals. 3) Lenacapavir, a novel capsid inhibitor with a long half-life, providing a new mechanism of action against HIV. 4) Potential vaccines in advanced stages of development, such as the mosaic-based vaccine candidates aiming to provide broad protection against diverse HIV strains.

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Monoclonal Antibodies

VRC01.23LS Antibody for HIV Prevention

Phase 1

Waitlist Available

Led By Lesia K Dropulic, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 weeks after last product administration

Awards & highlights

Summary

This trial will test if a new antibody, VRC01.23LS, is safe to inject in healthy adults.

Who is the study for?

Healthy adults aged 18 to 60 who are willing to have blood samples stored and used for research, can provide proof of identity, and agree to clinical follow-up. Women must use birth control and have a negative pregnancy test. Excluded are those with certain medical conditions, severe allergies, or recent receipt of other investigational products.Check my eligibility

What is being tested?

The trial is testing the safety of VRC01.23LS, an antibody that may prevent HIV infection. Participants will receive either one dose or three doses over several weeks via IV or subcutaneous injection in different body parts and will be monitored closely after administration.See study design

What are the potential side effects?

Potential side effects aren't detailed but monitoring includes checking temperature daily for a week post-injection and measuring any redness, swelling, or bruising at the injection site which suggests local reactions could be expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of VRC01.23LS (20 mg/kg IV) administered for a total of 3 injections in 12 week intervals to healthy adults

Safety and tolerability of VRC01.23LS (20 mg/kg IV) administered to healthy adults

Safety and tolerability of VRC01.23LS (40 mg/kg IV) administered to healthy adults

+3 more

Secondary outcome measures

PK will be evaluated at each dose level and route of administration.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Group 6Experimental Treatment1 Intervention

20 mg/kg IV repeat dosing

Group II: Group 5Experimental Treatment1 Intervention

5 mg/kg SC repeat dosing

Group III: Group 4Experimental Treatment1 Intervention

40 mg/kg IV single administration

Group IV: Group 3Experimental Treatment1 Intervention

20 mg/kg IV single administration

Group V: Group 2Experimental Treatment1 Intervention

5 mg/kg SC single administration

Group VI: Group 1Experimental Treatment1 Intervention

5 mg/kg IV single administration

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV/AIDS include antiretroviral therapies (ART) such as reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors. These drugs work by targeting different stages of the HIV life cycle: reverse transcriptase inhibitors block the conversion of viral RNA to DNA, protease inhibitors prevent the maturation of viral proteins, integrase inhibitors stop the integration of viral DNA into the host genome, and entry inhibitors prevent the virus from entering host cells. VRC01.23LS, an investigational antibody, works by binding to the HIV envelope protein, blocking the virus from attaching to and entering host cells. This is significant for HIV/AIDS patients as it offers a potential new method to prevent infection, complementing existing ART by targeting the virus before it can infect cells.

VCAM-1 as a Biomarker of Endothelial Function among HIV-Infected Patients Receiving and Not Receiving Antiretroviral Therapy.IAS Towards an HIV Cure Symposium: people focused, science driven: 18-19 July 2015, Vancouver, Canada.Case Report: No Response to Liposomal Daunorubicin in a Patient with Drug-Resistant HIV-Associated Visceral Leishmaniasis.

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,283 Previous Clinical Trials

5,498,892 Total Patients Enrolled

Lesia K Dropulic, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

4 Previous Clinical Trials

3,569 Total Patients Enrolled

Media Library

VRC-HIVMAB0115-00-AB (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05627258 — Phase 1

HIV/AIDS Research Study Groups: Group 4, Group 6, Group 3, Group 1, Group 5, Group 2

HIV/AIDS Clinical Trial 2023: VRC-HIVMAB0115-00-AB Highlights & Side Effects. Trial Name: NCT05627258 — Phase 1

VRC-HIVMAB0115-00-AB (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627258 — Phase 1

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