The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002363
- Lead Sponsor
- Columbia Research Laboratories
- Brief Summary
To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.
- Detailed Description
The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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)
Brown Univ School of Medicine
🇺🇸Providence, Rhode Island, United States