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

NCT ID: NCT00002051

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Thymopentin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunobiology Research Institute

INDUSTRY

Sponsor Role lead

Locations

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Immunobiology Research Institute

Annandale, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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H87-101

Identifier Type: -

Identifier Source: secondary_id

015E

Identifier Type: -

Identifier Source: org_study_id