- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002049
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Annandale, New Jersey, United States, 088010999
- Immunobiology Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent.
Patients with HIV "wasting syndrome" are included.
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.
- 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 (except for those with HIV "wasting syndrome").
- 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- 015B
- H87-047
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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