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

I

Immunobiology Research Institute

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Thymopentin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002051
015E
H87-101

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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