Search / Trial NCT00002363

The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

Launched by COLUMBIA RESEARCH LABORATORIES · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • 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.

About Columbia Research Laboratories

Columbia Research Laboratories is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a commitment to rigorous scientific methodologies and ethical standards, the organization specializes in designing and conducting clinical trials across a range of therapeutic areas. Columbia Research Laboratories collaborates with healthcare professionals and institutions to ensure the highest quality of data collection and analysis, ultimately striving to improve patient outcomes and contribute to the development of safe and effective medical treatments. Their experienced team is focused on fostering partnerships that enhance the clinical research landscape while prioritizing participant safety and regulatory compliance.

Locations

Providence, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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