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A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
This study has been completed.
Study NCT00002332   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002332 on ClinicalTrials.gov Archive Site
 
 
 
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy

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

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

Phase II
Interventional
Treatment, Double-Blind, Efficacy Study
HIV Infections
Drug: Thymopentin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002332
 
015I, 07.32.039-94
Immunobiology Research Institute
 
 
NIH AIDS Clinical Trials Information Service
December 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP