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.
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.
- Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study
Patients must have:
- HIV seropositivity for at least 6 months.
- CD4 >= 100 cells/mm3.
- HIV RNA PCR (Amplicor) > 10,000 copies/ml.
- No significant active opportunistic infection or tumor at study entry.
- The FDA encourages the inclusion of females of childbearing potential in study
protocols, but the sponsor of this protocol specifically excludes females of
childbearing potential from this study and includes only females who are sterile. Any
questions about these inclusion/exclusion criteria should be directed to the study's
- Prior antiretrovirals.
Patients with the following conditions are excluded:
Inability to communicate with investigator or deemed likely to be noncompliant on study.
- Any drug that may interact with SPC3 (e.g., suramin).
Patients with the following prior condition are excluded:
History of relevant drug hypersensitivity.
- Investigational drug within the past 4 weeks.