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 Medication:
Allowed:
- Aerosolized pentamidine.
Prior Medication:
Allowed:
- Aerosolized pentamidine.
Exclusion Criteria
Co-existing Condition:
- Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.
Concurrent Medication:
Excluded within 90 days of study entry:
- Zidovudine (AZT).
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:
- Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
- AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
- Significant hepatic disease.
- Thrombocytopenia (< 75000 platelets/mm3).
- Patient must voluntarily sign consent and be 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.
- Patients with HIV "wasting syndrome" are included.
- 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/NCT00002066
Study ID Number: 015A
ClinicalTrials.gov Identifier: NCT00002066
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002066
