- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002050
A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
June 23, 2005 updated by: Immunobiology Research Institute
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Annandale, New Jersey, United States, 088010999
- Immunobiology Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 1989
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Thymopentin
Other Study ID Numbers
- 015D
- H87-75
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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