NCT00002050CompletedNot Applicable
A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Immunobiology Research Institute2 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 2
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •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:
- •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.
Investigators
Study Sites (2)
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