A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
NCT ID: NCT00002332
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Thymopentin
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Immunobiology Research Institute
INDUSTRY
Locations
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Dr Marcus Conant
San Francisco, California, United States
Dr Jeffrey Galpin
Tarzana, California, United States
Novum Inc
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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07.32.039-94
Identifier Type: -
Identifier Source: secondary_id
015I
Identifier Type: -
Identifier Source: org_study_id