Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix (NCT07182838) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
United States20 participantsStarted 2025-09-12
Plain-language 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. Activate Human Antigen Presentation Reaction to HIV Specific Antigen.
3. 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.
Who can participate
Age range
24 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients.
* 20 HIV (+) patients
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of HIV (+) Participants:
Timeframe: Duration up to 4 weeks
2
Rate of Positive HIV nucleic acid:
Timeframe: Duration up to 4 weeks
3
Rate of Negative HIV nucleic acid:
Timeframe: Duration up to 4 weeks
4
20 HIV (+) Participants with IGRA blood test with HIV antigens
Timeframe: Duration up to 4 weeks
5
20 HIV (+) Participants with IGRA blood test with TB antigens