HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
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.
Interventions
DRUGPeptide Construction 3, Synthetic
Sponsors
Columbia Research Laboratories
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening. 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. FDA DISCLAIMER: * 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 contact person. Prior Medication: Allowed: * Prior antiretrovirals.
Countries
United States
Outcome results
None listed