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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002363
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: Peptide Construction 3, Synthetic Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 20
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002363


Locations
United States, Rhode Island
Brown Univ School of Medicine
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Columbia Research Laboratories
  More Information

ClinicalTrials.gov Identifier: NCT00002363     History of Changes
Other Study ID Numbers: 257A
SPC3-US1
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: April 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases