HIV InfectionsEarly Phase 1HIVGP-BCGNCT07182838

Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix

A Early Phase 1 study testing HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use in people with HIV Infections, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1. Treat Infection of Multiple Gene Mutation HIV Virus Strains. 2. Read more about this study

Who is it for?: Ages 24 to 64 years
Conditions the study is for: HIV Infections
What is being tested?: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2026to 28 Oct 2027
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

HIV Positive
Positive testing by standard RT-PCR assay or equivalent testing
No AIDS Symptoms
No clinical signs indicative of Severe or Critical Illness Severity
Sign Informed Consent Form

Who cannot join

Severe or Critical Illness Severity
Pregnancy
Breast-feeding
The patients with other serious inter-current illness
Serious Allergy
Serious Bleed or Clot Tendency
Serious side-effects of the biological product
The prohibition of the biological product

Trial locations and contacts

1 site in 1 country.

United States1 site

Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701
Rockville, Maryland, 20853

Other trials in United States

About this study

Official title: Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of HIV (+) Patients

Treat Infection of Multiple Gene Mutation HIV Virus Strains.
Activate Human Antigen Presentation Reaction to HIV Specific Antigen.
The human antigen presenting cells (APCs) can take up and process HIV target antigen protein into small peptide fragments, and then HIV virus can be killed by APCs directly.

Read the detailed description

Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients without AIDS
20 HIV (+) patients with AIDS
Positive HIV testing by standard RT-PCR assay or equivalent testing
No symptoms of AIDS
No clinical signs indicative of Severe or Critical Illness Severity
HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix
By the percutaneous route with the multiple puncture device
Negative HIV testing by standard RT-PCR assay or equivalent testing after percutaneous use 3 weeks.
Positive IGRA blood test with GP160 antigen after percutaneous use 21 days.
Our trial duration will be up to 4 weeks.

Conditions: HIV Infections
Being tested: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
Keywords: HIV, AIDS, GP160, BCG
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous useBiological
Also called GP160 plus BCG Vaccine Mix
- By the percutaneous route with the multiple puncture device
- HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix

Study groups in NCT07182838
Study group	Role	What they receive
Assess for therapeutic biologics activity (proof-of-concept)	Experimental	Therapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG Receives: Biological: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of HIV (+) Participants:
- 20 HIV (+) patients
- Positive HIV testing by standard RT-PCR assay
- No AIDS Symptoms
- No clinical signs indicative of Severe or Critical Illness Severity
Measured: Duration up to 4 weeks
Rate of Positive HIV nucleic acid:
- 20 HIV (+) patients
- Positive HIV testing by standard RT-PCR assay immediately
- HIV nucleic acid testing, assessed by RT-PCR Assay Kit
- Rate of Positive HIV nucleic acid must be 100%
Measured: Duration up to 4 weeks
Rate of Negative HIV nucleic acid:
- 20 HIV (+) patients
- HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Negative HIV by standard RT-PCR assay after percutaneous use 3 weeks
- HIV nucleic acid testing, assessed by RT-PCR Assay Kit
- Rate of Negative HIV nucleic acid will be more than 70%
Measured: Duration up to 4 weeks
20 HIV (+) Participants with IGRA blood test with HIV antigens
- Positive IGRA blood test with HIV GP160 antigen after percutaneous use 3 weeks
Measured: Duration up to 4 weeks
20 HIV (+) Participants with IGRA blood test with TB antigens
- Negative IGRA blood test with TB antigens before percutaneous use
- Positive IGRA blood test with TB antigens after percutaneous use 3 weeks
Measured: Duration up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202628 Oct 2027

First posted19 Sep 2025
Study start5 Oct 2026
Primary completion18 Jun 2027 (estimated)
Study completion28 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: Single Usage / Single Dosage
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07182838
Sponsor's protocol ID: IND 179135 Research
Other IDs: FWA00015357, IRB00009424, IORG0007849, NPI-1831468511, NPI-1023387701, IND 179135
Acronym: HIVGP-BCG
Status last verified: Oct 2026
First submitted: 12 Sep 2025
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
PubMed 27102489
Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
PubMed 32132681

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of HIV (+) Patients
ClinicalTrials.gov ID: NCT07182838
Acronym / sponsor ID: HIVGP-BCG / IND 179135 Research
Conditions: HIV Infections
Keywords: HIV, AIDS, GP160, BCG
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB ChairIndustry (pharma, biotech, devices)
Collaborators: UnitedHealthcare
Study start: 5 Oct 2026 (actual)
Primary completion: 18 Jun 2027 (estimated)
Study completion: 28 Oct 2027 (estimated)
First posted: 19 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Treat Infection of Multiple Gene Mutation HIV Virus Strains.
Activate Human Antigen Presentation Reaction to HIV Specific Antigen.
The human antigen presenting cells (APCs) can take up and process HIV target antigen protein into small peptide fragments, and then HIV virus can be killed by APCs directly.

Detailed description

Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients without AIDS
20 HIV (+) patients with AIDS
Positive HIV testing by standard RT-PCR assay or equivalent testing
No symptoms of AIDS
No clinical signs indicative of Severe or Critical Illness Severity
HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix
By the percutaneous route with the multiple puncture device
Negative HIV testing by standard RT-PCR assay or equivalent testing after percutaneous use 3 weeks.
Positive IGRA blood test with GP160 antigen after percutaneous use 21 days.
Our trial duration will be up to 4 weeks.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Usage / Single Dosage

Arm	Type	Receives
Assess for therapeutic biologics activity (proof-of-concept)	Experimental	Biological: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous useTherapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG

Who may qualify

Ages: 24 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

HIV Positive
Positive testing by standard RT-PCR assay or equivalent testing
No AIDS Symptoms
No clinical signs indicative of Severe or Critical Illness Severity
Sign Informed Consent Form

Key exclusion criteria (8 listed)

Severe or Critical Illness Severity
Pregnancy
Breast-feeding
The patients with other serious inter-current illness
Serious Allergy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous useAlso: GP160 plus BCG Vaccine Mix* By the percutaneous route with the multiple puncture device * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix	Biological	Assess for therapeutic biologics activity (proof-of-concept)

Primary outcome

Number of HIV (+) Participants:
Time frame: Duration up to 4 weeks
* 20 HIV (+) patients * Positive HIV testing by standard RT-PCR assay * No AIDS Symptoms * No clinical signs indicative of Severe or Critical Illness Severity
Rate of Positive HIV nucleic acid:
Time frame: Duration up to 4 weeks
* 20 HIV (+) patients * Positive HIV testing by standard RT-PCR assay immediately * HIV nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Positive HIV nucleic acid must be 100%
Rate of Negative HIV nucleic acid:
Time frame: Duration up to 4 weeks
* 20 HIV (+) patients * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative HIV by standard RT-PCR assay after percutaneous use 3 weeks * HIV nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative HIV nucleic acid will be more than 70%
20 HIV (+) Participants with IGRA blood test with HIV antigens
Time frame: Duration up to 4 weeks
- Positive IGRA blood test with HIV GP160 antigen after percutaneous use 3 weeks
20 HIV (+) Participants with IGRA blood test with TB antigens
Time frame: Duration up to 4 weeks
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 3 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Background: PubMed 27102489Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
Background: PubMed 32132681Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
FWA00015357Link provided by the sponsor.
IRB00009424Link provided by the sponsor.
IORG0007849Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

HAN XU, MD/PhD/FAPCR study chair

Medicine Invention Design Incorporation - IRB00009424

HAN XU, MD/PhD/FAPCR study director

Medicine Invention Design Incorporation - IORG0007849

HAN XU, MD/PhD/FAPCR principal investigator

Medicine Invention Design Incorporation - NPI 1023387701

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of HIV (+) Participants: (time frame: Duration up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07182838, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.