NCT00002332

Brief Summary

To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

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

December 1, 1995

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

ThymopentinAIDS-Related Complex

Interventions

ThymopentinDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS).
  • CD4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment).
  • Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known hypersensitivity to thymopentin or any component of the formulation.
  • Significant chronic underlying medical illness that would impede study participation.
  • Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment.
  • Concurrent Medication:
  • Excluded:
  • Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine.
  • HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry.
  • Patients with the following prior condition are excluded:
  • Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry.
  • Prior Medication:
  • Excluded:
  • Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry.
  • Required:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr Marcus Conant

San Francisco, California, 94115, United States

Location

Dr Jeffrey Galpin

Tarzana, California, 91356, United States

Location

Novum Inc

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

Thymopentin

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

Intervention Hierarchy (Ancestors)

ThymopoietinsThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
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: 1995-12

Locations

US(3)