Status:
ACTIVE_NOT_RECRUITING
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborating Sponsors:
UnitedHealthcare
Conditions:
HIV Infections
Eligibility:
All Genders
24-64 years
Phase:
EARLY_PHASE1
Brief 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...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07182838
Start Date
September 12 2025
End Date
October 28 2026
Last Update
October 7 2025
Active Locations (1)
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1
Medicine Invention Design Incorporation - IORG0007849 - NPI 1023387701
Rockville, Maryland, United States, 20853