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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peptide Construction 3, Synthetic
Sponsored by
Columbia Research Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brown Univ School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Columbia Research Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002363
Brief Title
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Official Title
Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia Research Laboratories

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peptide Construction 3, Synthetic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Brown Univ School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

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

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