NCT00002049

Brief Summary

Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings of patients infected with HIV who do not yet have AIDS.

Trial Health

80
On Track

Trial Health Score

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

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

August 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

SemenThymopentinLeukocytes, MononuclearHIV SeropositivityAIDS-Related Complex

Interventions

ThymopentinDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine.
  • Patients must have the following:
  • \- Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent.
  • Patients with HIV "wasting syndrome" are included.
  • Prior Medication:
  • Allowed:
  • Aerosolized pentamidine.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
  • Significant hepatic disease.
  • Thrombocytopenia.
  • Hypersensitivity to thymopentin.
  • Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
  • Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.
  • Patients with the following are excluded:
  • AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
  • Significant hepatic disease.
  • Thrombocytopenia.
  • Hypersensitivity to thymopentin.
  • Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
  • Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunobiology Research Institute

Annandale, New Jersey, 088010999, United States

Location

MeSH Terms

Conditions

HIV InfectionsHIV SeropositivityAIDS-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
not applicable
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: 1989-08

Locations

US(1)