CLINICAL TRIAL

VRC-HIVMAB0102-00-AB for Human Immunodeficiency Virus (HIV) Infections

Recruiting · 18 - 65 · All Sexes · Bethesda, MD

VRC 611: Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS)Administered Via Subcutaneous and Intravenous Injection in Healthy Adults

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About the trial for Human Immunodeficiency Virus (HIV) Infections

Treatment Groups

This trial involves 2 different treatments. VRC-HIVMAB0102-00-AB is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
VRC-HIVMAB0102-00-AB
BIOLOGICAL
Experimental Group 2
VRC-HIVMAB0102-00-AB
BIOLOGICAL

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Able and willing to complete the informed consent process
You are able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. show original
Available for clinical follow-up through the last study visit
You are between the ages of 18 and 60 years. show original
You are medically well and without clinically significant findings within 84 days prior to enrollment. show original
Weight 115 kg
You are willing to have blood samples taken and stored indefinitely and used for research purposes. show original
WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
Platelets = 125,000 500,000/mm3
The WBC count is between 2,500 and 12,000 per microliter of blood. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Throughout the study
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Throughout the study.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether VRC-HIVMAB0102-00-AB will improve 1 primary outcome and 1 secondary outcome in patients with Human Immunodeficiency Virus (HIV) Infections. Measurement will happen over the course of Throughout the study.

To evaluate the pharmacokinetics of CAP256V2LS
THROUGHOUT THE STUDY
The pharmacokinetics of CAP256V2LS administered.
To evaluate the safety and tolerability of CAP256V2LS
THROUGH 24 WEEKS AFTER PRODUCT ADMINISTRATION
5mg/kg SC of CAP256V2LS administered to healthy adults.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can human immunodeficiency virus (hiv) infections be cured?

Although it appears that long-term antiretroviral drug treatment in HIV-infected individuals can decrease the likelihood of new infection, it is not possible to definitively eliminate HIV infection.

Anonymous Patient Answer

What is human immunodeficiency virus (hiv) infections?

HIV infections are a leading cause of illness and death worldwide. With approximately 39 million people living with HIV infections in 2015, HIV is currently the focus of tremendous public health and vaccine development efforts. The term "human immunodeficiency virus" is often used as an umbrella term to describe the disease caused by hiv infections. But it also represents an infected carrier of a virus responsible for the development of acquired immune dysfunction and death (AIDS). HIV infections have been studied with great clinical and virological detail, and many research advances have been made in the search for a vaccine. Vaccines are the safest way to protect against infections.

Anonymous Patient Answer

What are the signs of human immunodeficiency virus (hiv) infections?

Symptoms of HIV infection include high fever, night sweats, painful or swollen lymph nodes, itching and rash. The symptoms of Kaposi's syndrome include a new skin eruption, an extra thickening of the skin over large portions of the body, a red, swollen lymph node, a swollen liver, and a swollen spleen. There may be swelling in the abdomen but these are nonspecific. A definitive diagnosis of HIV infection requires a test for HIV IgG or IgM antibodies in the person's blood, or for HIV-RNA in the blood or saliva.

Anonymous Patient Answer

What are common treatments for human immunodeficiency virus (hiv) infections?

HIV-related medications are often the first-line treatment when HIV infection develops in a new host. The most common new infections were attributable to injecting drug use and bisexual transmission. The antiviral medication most frequently prescribed to a patient with newly-acquired viral infection was at least one protease inhibitor. In general, antiretroviral-based combinations are more effective in suppressing disease progression than simple antiretroviral drugs alone.

Anonymous Patient Answer

What causes human immunodeficiency virus (hiv) infections?

This information is important since HIV infection is a primary concern for health planners in developing countries due to the global epidemic of the disease.

Anonymous Patient Answer

How many people get human immunodeficiency virus (hiv) infections a year in the United States?

The estimated number of new diagnoses of HIV infection each year in the United States is over 3.1 million, with nearly one in five individuals being infected with HIV. HIV transmission is thought to be the primary means by which the virus is spreading throughout the United States. In terms of both absolute number and the absolute percentage of people affected, the number of American adults living with HIV infection is on the rise in the United States. More frequent HIV testing will be required to detect the increasing numbers of people whose status is unclear. A major concern is a lack of access to treatment, since 30,000 Americans die from complications arising from the lack of treatment annually. The public health consequences of the HIV crisis in the United States are many and varied.

Anonymous Patient Answer

How serious can human immunodeficiency virus (hiv) infections be?

HIV infection was associated with the highest risk of death of all known causal infections. This risk grew with the number of sexual or intravenous receptive partner penetrations and the viral load at the time of diagnosis, indicating the importance of the early and effective treatment. In the absence of therapy, HIV infections often progressed to AIDS, resulting in a five-year survival rate of less than 10%.

Anonymous Patient Answer

What are the latest developments in vrc-hivmab0102-00-ab for therapeutic use?

A phase 1 trial conducted in the United States found no evidence of viral reactivation in any of the subjects. No safety concerns were identified for vrc-hivmab0102-00-ab in this or any other phase 1 clinical studies in HIV-1-infected volunteers.

Anonymous Patient Answer

Is vrc-hivmab0102-00-ab safe for people?

There is no reason to believe that Vrc-hivmab0102-00-ab would have been unsafe in healthy HIV-1 seronegative individuals. Furthermore, there is compelling evidence that this antigen-antibody combination formulation has a broad impact on immune function and can exert potent sterilizing activity both in healthy HIV-1 seronegative and HIV-1 seropositive individuals.

Anonymous Patient Answer

What is the primary cause of human immunodeficiency virus (hiv) infections?

HIV infections represent an [outstanding health problem] in the developed world: 1.8 million [new cases] every year (U.S. Centers for Disease Control and Prevention, 1991), and an [increasing fraction] of U.S. adults are living with HIV. The [cause] of this [outstanding health problem] lies [in some way or other] in heterosexual intercourse; no one knows how it [HIV infections] arose (AIDHA, 2001). Most HIV-1 infections are [acquired] through heterosexual sex [involving a female infected with HIV-1] (Kramer, 1993).

Anonymous Patient Answer

What does vrc-hivmab0102-00-ab usually treat?

Results suggest that Vrb-hivmab0102-00-ab reduces viral load in HIV-infected patients from moderate to severe acute viral replication within their first five days of therapy, with viral load rebound observed at 10 days after stopping anti-HIV therapy. Patients with higher CD4+ cell counts before commencing antiviral therapy may benefit less drastically from treatment.

Anonymous Patient Answer

Does human immunodeficiency virus (hiv) infections run in families?

Transmission of hiv among spouses was high among HIV-infected couples. This suggests that HIV risk among heterosexuals may be due to a complex interaction of individual and familial risk factors.

Anonymous Patient Answer
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