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A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

NCT ID: NCT00002050

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 Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to 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 Medication:

Allowed:

* Aerosolized pentamidine.

Patients must have the following:

* Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' PBMC on two separate occasions.
* Voluntarily sign consent.
* Patients with HIV "wasting syndrome" are allowed.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

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

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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H87-75

Identifier Type: -

Identifier Source: secondary_id

015D

Identifier Type: -

Identifier Source: org_study_id