Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002051
- Run by
- Immunobiology Research Institute
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Treatment:
- Allowed:
- Aerosolized pentamidine.
- Prior Medication:
- Allowed:
- Aerosolized pentamidine.
You may not qualify if…
- 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.
Where it is running
- Immunobiology Research Institute — Annandale, New Jersey, United States
Full record on ClinicalTrials.gov
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