Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
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...
Brief Summary
Official Title: “Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection”
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 Type: Interventional
- Study Design: Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Thymopentin
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Immunobiology Research Institute Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002051
Study ID Number: 015E
ClinicalTrials.gov Identifier: NCT00002051
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002051
