A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002353
- Lead Sponsor
- United Biomedical
- Brief Summary
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.
- Detailed Description
Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Hosp
🇺🇸Boston, Massachusetts, United States