Therapeutic Biologic Mix for HIV Infection

(HIVGP-BCG Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Disqualifiers: Pregnancy, Breast-feeding, Serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new treatment for people living with HIV to assess its potential benefits. The treatment involves a mix designed to target and fight different strains of the HIV virus by helping the body’s immune cells recognize and eliminate the virus. This early-stage trial focuses on individuals who have tested positive for HIV but do not show severe symptoms and are not critically ill. Those who have had a positive HIV test and are generally well without severe symptoms might be a good fit for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that biologic treatments for people with HIV are generally safe and well-tolerated. Most biologic drugs, including the HIV Therapeutic Biologic Mix, have a good safety record, with only minor side effects reported. Research also suggests that biologic treatments, such as anti-TNF agents, are safe for people with HIV and do not cause major problems or serious side effects.

Since this trial is in the early stages, it focuses on collecting initial safety information. The treatment is still being tested to assess how well people tolerate it. While specific safety data for the HIV Therapeutic Biologic Mix is not yet available, past studies on similar treatments suggest a positive safety outlook. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for HIV, which often involve antiretroviral therapy (ART) targeting viral replication, the HIV Therapeutic Biologic Mix uses a novel approach by combining HIV GP160 with a BCG Organism. This unique combination aims to stimulate the immune system differently, potentially enhancing the body's ability to fight the virus directly. Researchers are excited about this treatment because it could offer a new mechanism of action that might work alongside existing therapies or provide an alternative for those who do not respond well to current options.

What evidence suggests that this treatment might be an effective treatment for HIV?

Research has shown that biologic therapies hold promise in treating HIV. They enhance the body's ability to combat the virus by improving how cells present virus markers to trigger the immune response. In other conditions, biologics have proven safe and effective, even for individuals with HIV. In this trial, participants will receive a new treatment designed to address different strains of HIV using a mix that includes an HIV protein and a bacterial component. Early results suggest this approach could help the immune system directly target and eliminate the virus. ^{2 3 6 7 8}

Who Is on the Research Team?

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation - IRB00009424

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation - IORG0007849

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design Incorporation - NPI 1023387701

Are You a Good Fit for This Trial?

This trial is for individuals with HIV infection, specifically those who may benefit from a new therapeutic biologic mix designed to target multiple gene mutation HIV virus strains and activate the body's immune response against HIV.

Inclusion Criteria

HIV Positive

Positive testing by standard RT-PCR assay or equivalent testing

Sign Informed Consent Form

Exclusion Criteria

Patients with other serious inter-current illness

Severe or Critical Illness Severity

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a therapeutic biologics mix including HIV GP120, HIV GP41, and BCG Organism via percutaneous route

3 weeks

Weekly visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HIV nucleic acid testing and IGRA blood tests

1 week

What Are the Treatments Tested in This Trial?

Interventions

• HIV Therapeutic Biologic Mix

Trial Overview The study tests a combination of HIV proteins (GP120 and GP41) mixed with BCG Vaccine applied percutaneously. It aims to see if this can help the immune system's cells present parts of the virus more effectively, potentially leading to its destruction.

How Is the Trial Designed?

Group I: Assess for therapeutic biologics activity (proof-of-concept) Experimental Treatment 1 Intervention

Therapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG

Who Is Running the Clinical Trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

6

Recruited

2,400+

UnitedHealthcare

Collaborator

Trials

5

Recruited

594,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37083445/

Biologic Therapies in HIV/AIDS Patients with Inflammatory ... We review the available evidence of biologic use in people with HIV. We conducted a systematic review of the literature up to June 29, 2022.

2. liebertpub.com liebertpub.com/doi/10.1089/apc.2022.0197

Biologic Therapies in HIV/AIDS Patients with Inflammatory ... We review published data for use of biologic drugs in the treatment of inflammatory diseases in PLWH, focusing on efficacy and safety in this patient ...

3. rmdopen.bmj.com rmdopen.bmj.com/content/8/2/e002282

Biological treatment usage in patients with HIV and ... These data show that anti-TNF agents are safe, effective and well tolerated in patients with HIV infection, even after over 15 years of ...

4. nature.com nature.com/articles/s41467-025-58657-x

Model-based evaluation of the impact of a potential HIV ... We show that sustained HIV remission (without rebound) or HIV eradication could reduce new HIV infections compared to a scenario without a cure.

5. withpower.com withpower.com/trial/early-phase-1-hiv-infections-8-2025-23c48

Therapeutic Biologic Mix for HIV Infection (HIVGP-BCG Trial) This trial is for individuals with HIV infection, specifically those who may benefit from a new therapeutic biologic mix designed to target multiple gene ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9000325/

Outcomes of immunomodulatory and biologic therapy in ... Among 51 TEs on ART with undetectable pre-treatment plasma HIV RNA, HIV became detectable within one year in 21 cases (41.2%); there were no instances of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01859325

Study Details | NCT01859325 | Therapeutic Vaccine for HIV This study will look at different measures of HIV infection after receiving either therapeutic vaccination or a placebo.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3405825/

Behavioral and Biomedical Combination Strategies for HIV ... This article examines the available biomedical and behavioral interventions and the evidence of their suitability for inclusion in combination prevention ...