NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingEARLY_Phase 1

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

Conditions: HIV Infections

Interventions: HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 24 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

* 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

Locations (1)

Rockville, Maryland, United States