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The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients

Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002289
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Semen, Thymopentin, Leukocytes, Mononuclear, HIV Seropositivity, AIDS-Related Complex

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.

Interventions

DRUGThymopentin

Sponsors

Immunobiology Research Institute
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Concurrent Medication: Allowed: * 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' peripheral blood monocytes (PBMC) on two separate occasions. * Voluntarily sign consent. * Patients with HIV wasting syndrome are allowed. Prior Medication: Allowed: * 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026