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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002363
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002363 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Peptide Construction 3, Synthetic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002363
257A, SPC3-US1
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Columbia Research Laboratories
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NIH AIDS Clinical Trials Information Service
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP