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OpenTrials
Completed

NCT Number: NCT00002051

Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Concurrent Treatment:

Allowed:

  • Aerosolized pentamidine.

Prior Medication:

Allowed:

  • Aerosolized pentamidine.

Exclusion criteria

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 (< 75000 platelets/mm3).
  • Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry.
  • Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
  • Known hypersensitivity to thymopentin.

Prior Medication:

Excluded within 30 days of study entry:

  • Immunomodulatory or experimental therapy.
  • Excluded within 90 days of study entry:
  • Zidovudine (AZT).

Patients must not have:

  • AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
  • Significant hepatic disease.
  • Thrombocytopenia (< 75000 platelets/mm3).

Patients with the following conditions are included:

  • Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
  • HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
  • HIV "wasting syndrome".
  • Must voluntarily sign consent.

History of intravenous drug abuse.

Treatment and study plan

Thymopentin

Drug

Sponsors and collaborators

Lead sponsor

Immunobiology Research Institute

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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