Trial | NCT00002051  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Thymopentin

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.
No Results Posted