The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
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.
Drug: Peptide Construction 3, Synthetic
||Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
||Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002363
|Brown Univ School of Medicine
|Providence, Rhode Island, United States, 02908 |
Columbia Research Laboratories
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
ClinicalTrials.gov processed this record on August 26, 2015
Acquired Immunodeficiency Syndrome