A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002332

Enrollment

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

Thymopentin, AIDS-Related Complex

Brief summary

To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

Detailed description

Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Interventions

DRUGThymopentin

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients must have: * Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS). * CD4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment). * Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Exclusion criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Known hypersensitivity to thymopentin or any component of the formulation. * Significant chronic underlying medical illness that would impede study participation. * Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment. Concurrent Medication: Excluded: * Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine. * HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry. Patients with the following prior condition are excluded: Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry. Prior Medication: Excluded: * Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry. Required: * Current nucleoside analog antiretroviral treatment. Required: * Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Significant active alcohol or drug abuse sufficient to prevent study compliance.

Countries

United States

Outcome results

None listed

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