CLINICAL TRIAL

Budigalimab for HIV Infections

Waitlist Available · 18+ · All Sexes · Bellaire, TX

Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

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About the trial for HIV Infections

Eligible Conditions
HIV Infections · Human Immunodeficiency Virus (HIV) Infections · Acquired Immunodeficiency Syndrome · Immunologic Deficiency Syndromes

Treatment Groups

This trial involves 4 different treatments. Budigalimab is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Placebo
DRUG
+
Budigalimab
DRUG
Experimental Group 2
Placebo
DRUG
Experimental Group 3
Placebo
DRUG
+
Budigalimab
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A person is in generally good health if their body mass index is between 18.0 and 35.0 kg/m2. show original
We asked participants to use a condom for HIV prevention from the first day of the study until the last. 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: Up to approximately 24 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to approximately 24 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Budigalimab will improve 6 primary outcomes in patients with HIV Infections. Measurement will happen over the course of Up to approximately 24 weeks..

Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
UP TO APPROXIMATELY 24 WEEKS.
Terminal phase elimination half-life (t1/2)
Maximum Serum Concentration (Cmax)
UP TO APPROXIMATELY 24 WEEKS
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax)
UP TO APPROXIMATELY 24 WEEKS
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
UP TO APPROXIMATELY 24 WEEKS
Area Under the Plasma Concentration-time Curve (AUC).
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
UP TO APPROXIMATELY 24 WEEKS
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
UP TO APPROXIMATELY 24 WEEKS
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines [which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.

Patient Q & A Section

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

What does budigalimab usually treat?

This article summarizes the indications for budigalimab in all indications in which it is used.\n\nA 2011-2012 European Study\n\nA 2006 American Study\n\nAn overview of clinical trials"

Anonymous Patient Answer

How does budigalimab work?

These data indicate that BDG therapy has little or no effect on immune activation, and suggests that, at least in the initial period of B cell activation, this BCR-mimetic lacks an anti-CD40 effect.

Anonymous Patient Answer

Can hiv infections be cured?

The HIV/AIDS epidemic cannot be won in the foreseeable future, and most patients with stable HIV infections will need lifelong treatment to suppress viral replication. Effective therapeutic strategies to control HIV, either directly or by indirect ways, require the full development of viral immunity and functional HIV-specific T cell responses.

Anonymous Patient Answer

What is hiv infections?

There is a need to focus on the management of HIV infection as an urgent public health issue due to its significant impact on health and the social and financial costs of treating people with AIDS and AIDS related diseases.

Anonymous Patient Answer

What causes hiv infections?

the virus itself doesn't directly cause AIDS, but certain viruses that cause AIDS worsen the chances that infected people will get it. But how is AIDS caused? HIV causes immunosuppression, the weakening of protective immunity that helps protect against diseases such as malaria and other opportunistic infections. The immunosuppression that occurs as a result of HIV infection also makes people at higher risk for developing all of the types of HIV-associated cancers.\n

Anonymous Patient Answer

What are the signs of hiv infections?

Signs of hiv infections are similar to signs of depression and are manifested by significant loss of appetite, weight loss and decreased appetite, fatigue, and sleep disturbances. Also hiv infection has a profound effect on the immune system as manifested by the onset of opportunistic infections.

Anonymous Patient Answer

What are common treatments for hiv infections?

The most common treatments for HIV are antiretroviral therapy in combination with other therapy, including antiproliferative therapy, anti-HIV treatment for opportunistic infections, immunosuppression, and prophylaxis against sexually transmitted infections. In the absence of effective treatment, individuals with HIV-related illnesses must rely on supportive care to maintain their health.

Anonymous Patient Answer

How many people get hiv infections a year in the United States?

About 8% of HIV-positive women in the U.S. have an HIV-positive husband/boyfriend or a sexual partner. As a result of this sexual link, about 24% of women with HIV are at high risk for acquisition of HIV. The sexual spread of AIDS may be much more common than is currently recognized, because HIV-positive men are less likely to have unprotected sex with females.

Anonymous Patient Answer

What is budigalimab?

Budigalimab is a mouse/human chimeric anti-CD20 antibody designed to selectively target CD20+ B-cells. This antibody is now used in clinical trials for chronic lymphocytic leukemia and Hodgkin's lymphoma.

Anonymous Patient Answer

Who should consider clinical trials for hiv infections?

Because no evidence-based treatment regimen currently exists for hiv infections, clinical trial participation may not be in the best interests of people diagnosed with HIV infection, particularly when considering the financial and time costs of clinical trial participation. However, if the potential benefits of clinical trial participation outweigh potential risks, more HIV infected individuals should consider participation.

Anonymous Patient Answer

Does budigalimab improve quality of life for those with hiv infections?

Budigalimab is the first therapy to produce improvements in quality of life, quality of appetite, and quality of sleep that are statistically significant and clinically relevant. Budigalimab is an effective treatment for CD22-positive B cells in patients with hiv, as assessed by the patient-reported outcomes of quality of life and quality of sleep and appetite.

Anonymous Patient Answer
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