NCT00002363

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral Agents

Interventions

Peptide Construction 3, SyntheticDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • Prior Medication:
  • Allowed:
  • Prior antiretrovirals.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown Univ School of Medicine

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Metabolism

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-04

Locations

US(1)