An Early Phase 1 interventional study of HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use in HIV Infections, sponsored by Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair. Active, not recruiting at 1 site in United States. Open to participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair · Early Phase 1, Interventional, and Health services research
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Among 2,802 studies in HIV Infections with a site in United States — 83 open to participants now, 140 under way, 11 of them phase 3. HIV Infections · United States.
Among the 2,802 studies in HIV Infections with a site in United States, this one is the 1,807th largest by planned enrollment of the 2,150 interventional ones that give a count, is one of 26 that started in 2026, is one of 671 in phase 1, reaches primary completion later than 68 of the 137 other live ones, and was the 2,779th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →83 of the 2,802 studies in HIV Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
Louisiana State University Health Sciences Center in New Orleans · Sites in United States
Ages 40+
American University · Sites in United States
Ages 18+ · Men only
Gilead Sciences · Sites in United States, Australia, Japan
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 24 Years to 64 Years · all sexes · no healthy volunteers.
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2,802 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 749 · Phase 2 588 · Phase 3 337 · Phase 4 157
First in 1984; this study’s year is marked. 26 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 60 across the 2,150 interventional studies, 135 across the 350 observational. Of the 2,530 that completed or were terminated, 558 (22%) have results posted.
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857 of 2,802 have an industry lead sponsor. The 10 most frequent:
Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair is the lead sponsor of 2 studies on the registry; none are open to participants now.
Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair has 1 study filed under HIV Infections — fewer than ten, so there is no comparison to draw.
51 of the studies in HIV Infections with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06550804Phase 3University of Illinois at ChicagoTesting a Real-time Electronic Antiretroviral Adherence Monitoring Intervention | 2027-03 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT04577313University of ConnecticutHIV Treatment Adherence Dose Determination Trial | 2026-11-30 |
| NCT06679751Boston Medical CenterInfectious Disease (ID) Testing OUtreach in Carceral Hubs | 2026-12 |
| NCT06868641Columbia UniversityThe TAIL-PrEP Study | 2026-12 |
Add all 51 to your calendar (.ics) → With an account.
Among the 2,802 studies in HIV Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapeutic Biological Product Mix activity - HIV GP160 0.1 mg x 1 mL add into BCG Organism 50 MG
Biological: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
* By the percutaneous route with the multiple puncture device * HIV GP160 0.1 mg x 1 mL plus BCG Organism 50 MG Mix
Also known as: GP160 plus BCG Vaccine Mix
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
Time frame: 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%
Time frame: 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%
Time frame: 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
Time frame: 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
Time frame: Duration up to 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.
Of 74 industry-sponsored phase 1 interventional studies under HIV Infections, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's planned 8 months is above that.
Counting every sponsor, half of 165 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: start Sep 2025 → Oct 2026, primary completion Aug 2026 → Jun 2027 and completion Oct 2026 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair