- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002363
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908
- Brown Univ School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Inability to communicate with investigator or deemed likely to be noncompliant on study.
Concurrent Medication:
Excluded:
- Any drug that may interact with SPC3 (e.g., suramin).
Patients with the following prior condition are excluded:
History of relevant drug hypersensitivity.
Prior Medication:
Excluded:
- Investigational drug within the past 4 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 257A
- SPC3-US1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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