NCT00002051CompletedNot Applicable
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
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 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 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 Treatment:
- •Aerosolized pentamidine.
- •Prior Medication:
- •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.
Investigators
Study Sites (2)
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