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A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
This study has been completed.
Sponsored by: Immunobiology Research Institute
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002332
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Thymopentin
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Thymopentin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Efficacy Study
Official Title: Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy

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

Estimated Enrollment: 60
Detailed Description:

Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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:

  • Current nucleoside analog antiretroviral treatment.

Required:

  • Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Significant active alcohol or drug abuse sufficient to prevent study compliance.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002332

Locations
United States, California
Dr Jeffrey Galpin
Tarzana, California, United States, 91356
Dr Marcus Conant
San Francisco, California, United States, 94115
United States, Pennsylvania
Novum Inc
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Immunobiology Research Institute
  More Information

Study ID Numbers: 015I, 07.32.039-94
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002332  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Thymopentin
AIDS-Related Complex

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Thymopentin
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009